the center for advanced reproductive services- farmington ...€¦ · ovulation induction /...

1 The Center for Advanced Reproductive Services- Farmington and Hartford

OVULATION INDUCTION / (Intrauterine Insemination) “IUI” PROGRAM Center for Advanced Reproductive Services

ON-LINE TEACHING PROGRAM FOR IUI INJECTABLE MEDICATIONS

FARMINGTON OFFICE: 860-679-4580

HARTFORD OFFICE: 860-525- 8283

IUI Teaching Class Handbook 6.14.01 MMR revised 9.04.01 8.4.02; 8.22.02;4.03; 5.13.03; 6.4.03; 4.16.04; 5.16.04; 8.17.05; 7.02.07; 11.08; 1.09; 4.09; 8.25.09 MMR SD: 8.17.05; 7.02.07; 4.09; 9.09

2 Welcome to the On-Line Ovulation Induction/IUI Teaching Program at The Center for Advanced Reproductive Services. Before starting your injectable medications, the following steps MUST be completed:

1. All medical pre-requisites prescribed by your physician must be completed. This includes update blood work, physical exams, HSGs etc.

2. Your insurance pre-authorizations must be completed with your Financial

Service Representative (FSR). 3. Once above completed, call your primary (“clinical”) RN to obtain

your medication plan and a list of medication videos that you will need to watch on-line through our website. (See “MEDICATION CHECKLIST ADDENDUM for list and website instructions)

4. You are responsible for thoroughly reading this entire Ovulation Induction/IUI handbook.

5. You are responsible for reviewing all assigned medication videos. See “MEDICATION CHECKLIST” ADDENDUM at the end of the packet.

6. Once you have reviewed both this teaching handbook AND the medication videos assigned by your primary (“clinical”) nurse, call the Center’s “Teaching Nurse” and leave a message at:

Farmington Office 860-679 – 4467 (teaching nurse) Hartford Office 860-525 – 8283 ext 14

7. Your call will be returned WITHIN A FEW DAYS to complete a

short phone interview to verify your understanding of your current medication protocol; to answer any questions that you might have; and to receive your actual prescription.

8. Consents MUST be signed BEFORE you may start medications. The consents (BOTH notary and non-notary) are found as an addendum at the end of this handbook. Please note: consents must be witnessed by an employee of our Center (not an acquaintance or relative) OR must be signed by a public notary.

9. Once all the above is completed, you will be able to start your cycle.

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TABLE OF CONTENTS

Part 1 About our Ovulation Induction Program Part 2 Steps Involved in a Cycle Part 3 Getting Started with your Cycle Part 4 Time to Review the Website Videos Addendums: 1. Helpful Hints for Injection Techniques Helpful Hints for Crinone Progesterone Helpful Hints for Endometrin Progesterone Helpful Hints for Progesterone Suppositories. 2. Medication Checklist 3. Injection Site Illustration 4. “Gonadotrophin” flow sheet (your medication plan) 5. Menopur visual instructions for use without Q cap. (same technique can also be used to mix “Luveris” medication)

6. “Superovulation” and “Intrauterine Inseminations (IUI)” Consents 7. On- Line Patient Education Questionnaire (please return this to

us- we appreciate your thoughts and suggestions)

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PART 1 ABOUT OUR OVULATION INDUCTION/IUI PROGRAM

IMPORTANT INFORMATION FOR YOU TO KNOW BEFORE AND DURING YOUR

CYCLE

WORKING WITH THE TEAM The doctors, nurses, laboratory, and office staff are all very invested in your care. This handbook was designed with your needs in mind to use as a reference and to encourage you to participate in your own care. IMPORTANT PHONE NUMBERS

• Farmington Office: 860-679-4580 • Hartford Office: 860-525-8283

Note: We have 2 clinical offices – both Farmington and Hartford. The Hartford office is closed on weekends and major holidays. All cycling ultrasounds, intrauterine inseminations, IVF procedures, and urgent/emergency care needs are performed ONLY at the Farmington office on weekends and major holidays. FOR AFTER HOUR AND WEEKEND EMERGENCIES: BOTH FARMINGTON AND HARTFORD OFFICES: If you have an emergency and it is after office hours or on weekends, call 860-679-4580 and ask for the physician on call. If it is a question or concern that can be answered during normal business hours, please leave a message on the nurses’ line and we will get back to you when the office re-opens. “CLINICAL NURSES” LINE: While you are preparing to cycle (that is, prior to actually starting your injections), call your clinical nurse for any questions or concerns you may have: For Dr. Nulsen’s patients 860-679- 3535 (Deb J. in Farmington) For Dr. Benadiva’s patients 860-679- 3144 (Helen in Farmington) For Dr. Schmidt’s patients 860-679- 3802 (Lisa in Farmington) For Dr. Engmann’s Farmington patients 860-679- 3802 (Lisa in Farmington) For Dr. Engmann’s Hartford patients 860-525- 8283 X 14 (Sophie, Sharon, Jan

in Hartford) For Drs DiLuigi’s and Olivar’s patients 860-525- 8283 X 14 (Sophie, Sharon, Jan

in Hartford)

• Do not leave an emergency message on this line. If your call is not urgent you may not hear from the clinical team until the following business day.

• Messages are not retrieved from these lines after hours or on weekends. However, on Mondays all calls received on the weekend will be retrieved.

5 ASSISTED REPRODUCTIVE TECHNOLOGIES (ARTS/IVF) NURSES” LINE: Once you are actually cycling on medications, that is, taking the injections, your care is coordinated by the “ARTs / IVF” Team:

(860) 679- 2923 for FARMINGTON OFFICE PATIENTS OR

(860) 525—8283 X 14 for HARTFORD OFFICE PATIENTS • Do not leave an emergency message on this line. If your call is not urgent you may

not hear from the ARTs/IVF team until the following day. • Messages are not retrieved from these lines after hours or on weekends. However,

on Mondays all calls received on the weekend will be retrieved.

IMPORTANT INSURANCE INFORMATION

Insurance company benefits vary greatly when it comes to infertility treatments. It is your responsibility to discuss benefit coverage with your Financial Service Representative (FSR) here at The Center BEFORE you begin your treatment plan. If you begin your treatment without completing the pre-certification process, you may be required to pay “out of pocket” for procedures, ultrasounds, lab services, blood work, and medications associated with your treatment. A start date from the medical staff does not mean that you are financially cleared. You must check with your FSR before beginning or making a change to your treatment plan. Before beginning treatment:

Dr. Nulsen’s patients: contact your FSR Susan @ (860) 679-2282 Dr. Benadiva’s patients: contact your FSR Chrissy @ (860) 679-2757 Dr. Schmidt’s patients: contact your FSR Doreen @(860) 679-3792 Dr. Engmann’s FARMINGTON patients: contact your FSR Doreen @(860) 679-3792 Drs Engmann in HARTFORD, DiLuigi or Olivar patients: contact your FSR Marie

@ (860) 525- 8283 X 1 IMPORTANT PRESCRIPTION MEDICATION INFORMATION Have your prescriptions filled by 1 week prior to your anticipated cycle start. Infertility medications are specialty items. This is why we have listed pharmacies that specialize in these medications. Your prescription will come with refills so you can call your pharmacy when necessary to activate the refills. Monitor your available medications so that you can order refills with enough lead time for delivery. Be prepared for the weekends when it is more difficult to obtain refills. It is your responsibility to activate the re-fills.

• Some insurance companies are specific and dictate which pharmacy you must go to for coverage. As a result, in certain circumstances, it may take you several weeks to obtain your medications.

Beacon (Southington) (860) 628-3972 Monday- Saturday Arrow (Hartford) (860) 727-1123 Monday-Saturday Village Pharmacy 877-334-1610 24 Hours (no Sunday delivery)

6 Freedom Drug 800-660-4283 24 Hours (no Sunday delivery) IVP 800-483-8001 24 Hours (no Sunday delivery) Schrafts 800-876-4545 24 Hours (no Sunday delivery) Oranoque (Stratford) 888-556-3313 24 Hours (no Sunday delivery) Apothecary by Design 877-814-8447 24 Hours (no Sunday delivery) Aetna Specialty 866-782-2779 (insurance specific) Caremark 877-269-4831 or 800-378-5697 (option 2) (insurance specific) Tel-Drug (Cigna) 800-351-3606 (insurance specific) Precision Rx (Anthem) 888-662-0944 (insurance specific) Medco 1-888-327-9791 (insurance specific) EMERGENCY MEDICATIONS: Walgreens Pharmacy (Southington store only) 24 Hour pharmacy 359 Main St 860-621-0273 Southington, CT We can also fax your prescription to any of these pharmacies as per your request. PRENATAL VITAMINS/FOLIC ACID; Begin taking prenatal vitamins before you start cycling. Several studies have shown that folic acid supplementation can significantly reduce the occurrence of neural tube defects in infants (such as spina bifida). This can be accomplished by taking the prenatal vitamin we have included in your prescription. This prescription contains 1 mg of folic acid. NON-PRESCRIPTION MEDICATIONS Please check with your primary care physician before taking any medications during your cycle. Some herbal medications (St. John’s Wart, Gingko, and Echinacea) have been found to be detrimental to eggs and sperm interaction. UConn Health Center does provide a “Pregnancy Riskline” to answer your questions related to medication and other exposures during pregnancy. You can contact the Riskline at 1-800-325-5391 or 860-679-8850. CAFFEINE AND SMOKING Eliminate cigarettes and minimize your intake of caffeine. Both of these substances have been shown to affect fertility. Switch to decaffeinated beverages if needed. CONSENTS

• Prior to beginning your ovulation induction therapy, your current SIGNED CONSENTS MUST BE IN YOUR MEDICAL RECORD. SEE ADDENDUMS.

• Consents must be witnessed by an employee of the center OR may be notarized. You may come in to the office Monday through Friday between 8 AM and 4:30 PM to have your consents witnessed OR use a notary at your convenience. SEE ADDENDUMS.

ANSWERING MACHINE OR VOICE MAIL Please have a functioning answering machine with either your first name or your phone number identified in the greeting so that we can leave a message on the answering machine if necessary. Check your answering machine/voice mail every day when you are cycling.

7 www.uconnfertility.com

• This is The Center’s own website which contains links to educational programs. • Click on to “Patient Education” and you will see a link to Village Pharmacy and

Freedom Fertility Pharmacy icons which have video and audio presentations on all medications and injection techniques. Specific instructions for these are your the Medication Checklist (See addendum at end of handbook)

• You will be given a list of your medications to review.

PART 2 – STEPS INVOLVED IN A CYCLE THE TYPICAL SEQUENCE OF EVENTS INVOLVED IN AN OVULATION INDUCTION CYCLE CONSISTS OF:

1. TAKING INJECTABLE MEDICATIONS These medications supplement the body’s production of the natural hormone FSH. This results in the development and maturation of multiple eggs during the woman’s “stimulated” menstrual cycle increasing the probability of pregnancy. Typically a woman takes these medications for approximately 8 to 10 days.

2. A TIMED, MIDCYCLE INJECTION of “HCG” MEDICATION A timed, midcyle, single injection of HCG hormone mimics the “LH surge” which is experienced during a normal menstrual cycle. This results in the final maturation and release of the eggs from the ovaries.

3. A TIMED INTRAUTERINE INSEMINATION (IUI) A timed intrauterine insemination (IUI). This brings the sperm in closer proximity to the eggs and increases the woman’s probability of pregnancy

4. ADDING PROGESTERONE The addition of Progesterone in the later half of the cycle supports the development of the uterine lining to nourish an embryo.

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PART 3 GETTING STARTED WITH YOUR CYCLE

1. We monitor your cycle with ultrasounds and blood work to evaluate your response

to the medications.

We schedule ultrasounds every 15 minutes so we are moving along at a fast pace. This is done intentionally so that we can help you get in and out as quickly as possible to avoid interrupting your work and personal schedules. Please be assured that you will get the time you need to address your personal needs. Each day your physician and the team will review your blood work and ultrasound results later in the day. Much of this is done by your own physician behind the scenes. If needed, you will receive a call from us to adjust or confirm you treatment plan.

FARMINGTON PATIENT APPOINTMENTS:

• Cycling ultrasounds are done by appointment between 7:30 AM and 9:30 AM in Farmington on the third floor. Please call for an appointment time.

HARTFORD PATIENT APPOINTMENTS:

• Cycling ultrasounds are scheduled in the Hartford office from 7:45 am to approximately 9:00 am. Please call for an appointment time.

2. Cycle Day #1 refers to the first day of “full flow”of your menstrual cycle. Any time

before midnight that your usual menses (period) starts with your usual “full flow”(not spotting) is called CYCLE DAY # 1

3. YOU NEED TO COME IN FOR A BASELINE ULTRASOUND AND BLOOD

WORK ON CYCLE DAY #2 OR # 3 BEFORE YOU START MEDICATIONS to be checked to be sure that it is safe to start your medications

4. Injectable medications are started on CYCLE DAY #2 or #3 after you have been

given the medical OK to start by the clinical team 5. To schedule your first ultrasound and blood work appointment follow these

instructions:

PATIENT INSTRUCTIONS FOR MAKING ULTRASOUND AND BLOOD WORK APPOINTMENTS

Make your life easier by following these simple instructions: Monday through Friday:

• If your menses (period) starts during the workday while our office is open (until 4:30 PM), please call your specific physician’s office (Farmington @ 860-679-

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4580 or Hartford @ 860-525-8283) to schedule your “baseline” appointment for the next day.

• If your menses starts after the offices are closed (after 4:30PM), please call your

specific physician’s office the following day during office hours to schedule your appointment for the NEXT day.

Weekends: Special Instructions

• If your menses starts on a Friday after our office is closed (4:30 PM), please come into the Farmington office at 8:30 AM on Sunday morning for your baseline ultrasound and blood work.

• If your menses starts on a Saturday before 4:30 PM, please come into the

Farmington office on Sunday at 8:30 AM for a baseline ultrasound and blood work.

• If your menses starts after 4:30 PM on a Saturday, please come into your specific physician’s office for a baseline ultrasound and blood work on Monday morning at

8:30 AM. • If your menses starts on a Sunday before 4:30 PM, please come into your specific

physician’s office on Monday at 8:30 AM for a baseline ultrasound and blood work. • If your menses starts on Sunday after 4:30 PM, please call your specific physician’s

office on Monday and schedule an appointment for an ultrasound and blood work on Tuesday morning.

GETTING BLOODWORK:

• It is imperative that your blood be drawn on the day it is ordered, at the Center’s blood drawing lab, and in a timely manner. We must have your results back early enough in the day (preferable by noon) so that we can evaluate results, make decisions, and communicate those decisions to you that same day. This is a critical component of your cycle.

• During your cycle your lab work MUST BE DRAWN EARLY IN THE MORNING BY 9:00AM to ensure that results are available in a timely manner for review at the team rounds.

• The Center’s Lab is the Preferred Lab for Patients. All cycling patients MUST have their cycling and follow-up bloods drawn at our offices in Farmington and/or Hartford. All labs have different assays and normal/abnormal ranges and it is important to have consistency. Our team is familiar with these lab assays and ranges and is most confident when making decisions. Furthermore, we receive your results without delay. Your blood must be drawn by 9:00 am to get timely results for your MD to review.

o A lab requisition is filled out by our clinical staff and will be held for you at our office.

o Plan to leave us a phone # at which we may reach you later that afternoon. We may need to call you to adjust your medication plan.

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*** ALL WEEKEND CYCLING LABWORK MUST BE DONE AT OUR FARMINGTON

OFFICE ONLY BETWEEN 7:30 AM and 9:00AM****

• Farmington Lab Hours Monday- Friday 7:00 – 9:00 AM Sat & Sunday 7:30 – 9:00 AM • Hartford lab Hours: Monday –Friday 7:30 – 9:00 AM Sat & Sunday 7:30 – 9:00 AM USE UCONN Farmington Office ONLY

• Quest and Community Hospitals are not acceptable for cycling and follow-up blood

work unless prior arrangements have been made with our staff for extreme circumstances. Assays may differ between labs interfering with appropriate interpretation and comparison of results for decision making. Community hospitals generally do not have a fast enough turn around time for us to appropriately monitor your cycle.

RESULTS AND CALL BACKS: Blood work results are not available to us until the afternoon and are then reviewed by the medical team. If we did not give you instructions at your morning ultrasound, then we will call you in the afternoon with your plan. Expect to hear from us between 1:30 PM and 4:00 PM. If you do not hear from us by 4:00 PM, please call the office. POTENTIAL RISKS AND SIDE EFFECTS ASSOCIATED WITH STIMULATION MEDICATIONS

• Monitoring during your stimulation phase is necessary to help prevent untoward

side effects from your medications such as “Ovarian Hyperstimulation”. • Hyperstimulation may result from too exuberant a response by your ovaries to your

stimulation medications. • If monitoring indicates that your ovaries are responding too exuberantly to your

medications, your medication dosage may be adjusted, or you may be counseled about canceling your cycle if you are at increased risk for significant HYPERSTIMULATION or High Order MULTIPLE PREGNANCIES (triplets or greater).

1. MEDICATION SIDE EFFECTS

o side effects which may be observed during a medication cycle are breast

tenderness, mood swings, bloating, fatigue and pelvic discomfort related to ovarian enlargement. Some women form cysts on their ovaries after ovulation. These cysts do not usually cause problems other than pelvic fullness. Sometimes they grow excessively (size of an orange) and may cause

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abdominal pain or bloating. The resulting condition is referred to as HYPERSTIMULATION. Significant hyperstimulation, however, is a relatively infrequent occurrence in IUI cycles since relatively small amounts of ovarian stimulation medication are used (compared to an “IVF” In Vitro Fertilization cycle for example). Typically, if hyperstimulation symptoms occur, symptoms generally occur about 1 week after your HCG trigger injection. Please call us if you develop any problems during this time particularly if you experience dizziness, decreased urination, shortness of breath, severe abdominal pain, or weight gain of more than 3 pounds. These cysts usually start to resolve by the 12th day after your injection of “HCG” unless you conceive. With pregnancy, the symptoms of HYPERSTIMULATION may last a little longer. Hyperstimulation treatment usually consists of bedrest and increased fluids, especially Gatorade, Powerade, V-8 juice, or canned soups which all contain fluid and electrolytes.

2. MULTIPLE BIRTHS

• Stimulation drugs are associated with an increased risk of multiple birth. The incidence of multiple birth is approximately 20%, usually twins. About 5% of the total pregnancies result in triplets or more. Additionally there may be a slight increase in the rate of miscarriage.

3. OVARIAN CANCER

• Several things contribute to a woman’s risk of developing ovarian cancer. These include family history of ovarian cancer, personal history of other cancers, and reproductive history. Not experiencing pregnancy in itself is associated with an increased risk of developing ovarian cancer. The more times a woman ovulates in her lifetime, the higher her risk of developing ovarian cancer. For example, a woman who experienced her first menstrual period at a young age, never has a pregnancy, and undergoes menopause at a late age has a higher risk of ovarian cancer than a woman who had a late first period, had several pregnancies and breastfed afterwards, then an early menopause. Birth control pills are protective against ovarian cancer because they prevent ovulation. Most studies have found that ovulation medications do not increase the risk of either ovarian or breast cancer. At this time, there is no definitive evidence to prove that a relationship exists between infertility medications and ovarian cancer. The American Society for Reproductive Medicine came out with this statement in 2002: “More recent research indicates that patients taking ovulation-inducing drugs face no greater cancer risk than the general population”. Although future studies could find an association, at this time ovulation-inducing medications appear to be safe for short-term use and do not appear to cause ovarian cancer.

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ABOUT SUPPRESSION WITH GANIRELIX ACETATE or CETROTIDE

• On occasion, some women may benefit from a medication which helps to prevent the body from prematurely releasing a naturally occurring hormone “LH”. LH allows the egg to burst forth from the follicle. If this happens too early, the eggs may not be mature enough to be successfully fertilized by sperm.

• Medications, marketed under such names as GANIRELIX ACETATE and CETROTIDE, can suppress the body’s normal LH surge and prevent the eggs from being released too early.

• If this medication applies to you, we will indicate this to you specifically in your plan and please see the following instructions:

• Ganirelix Acetate comes in a prefilled syringe that is ready to administer.

• Cetrotide comes in a ready to mix “kit” • You will be given specific instructions on when to start these

medications. It depends on your cycle day, the size of your follicles and/or your estrogen blood work results. Generally, this medication is started about half way through your cycle.

• Once you start cycling, carry one of these prefilled syringes or kits in your purse with you. This way you will be ready to take the medication when directed to do so

• These medications are typically administered in the MORNING • The medication is a “short” needle injection and is given in the

abdomen or outer thigh area. • If applicable, review the instructions for the administration of this

medication on our website

13 ABOUT YOUR HCG “TRIGGER” MEDICATION

• When both your blood work and ultrasound results indicate that the eggs should be

mature, you will be instructed to stop your stimulation medications and instead use an injectable medication that evening called “HCG”( Human Chorionic Gonadotrophin). “HCG” is taken to “trigger” the release of the eggs. Brand names for this same medication include Novarel and Pregnyl.

• “HCG” causes the final maturation of the eggs and the release of the eggs from the ovaries for fertilization.

• “HCG” MUST BE TAKEN AT THE PRESCRIBED TIME to coordinate with your insemination. Generally this time is between 8:00 PM and 10:00 PM

• HCG is generally prescribed in a 10,000 unit dose. The dose may at times be adjusted. If this is the case, we will give you special instructions at the time.

• HCG is a single dose medication and is given with a short needle (subcutaneously) into the abdomen or outer thigh. (Note: the HCG box indicates intramuscular use (long needle injection) but now the accepted practice is to give it as a subcutaneous (short needle) injection.)

Note:

• The day you are instructed to take your “HCG”, you will also be given an appointment for your partner to produce a sperm sample to be processed for your IUI.

• If you live within a one hour drive from The Center, your partner can produce the sample at home and drop it off at The Center between 7:30 AM and 8:30 AM. The sample should be protected from heat and cold. A suggestion is to transport the container tucked inside his shirt so that body heat maintains the sample. We will give you the container for this. Your partner will need to drop off the sample and bring a photo ID (driver’s license) with him.

• Note: If your partner cannot drop off the sample himself in the morning, then you may strongly wish to have him arrange an appointment here at the center to produce a sample for cryopreservation (freezing). This way the sample will be available to you if such a situation arises. Call 860-679-4580 (Farmington) or 860-525-8283 (Hartford) to make an appointment for this.

• If your partner will produce the sample here in the office, he will need to be here at 8:00 AM. There are 2 “production” rooms at The Center in Farmington and one in Hartford. Therefore, there may be a delay in room availability depending upon the particular day.

• If your partner’s sperm is being used for the insemination (as opposed to donor sperm), it would be ideal if he abstains from ejaculating for at least 2 days, but not more than 5 days prior to the insemination.

• Processing the sample takes approximately 2 hours. You will be asked to return to The Center for your IUI procedure at 11:00 AM.

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ABOUT YOUR INTRAUTERINE INSEMINATION (IUI)

• An intrauterine insemination is a procedure which allows sperm to be deposited directly inside the uterus.

• The purpose of the IUI is to increase the woman’s ability to become pregnant by both washing the sperm to enhance its motility and by mechanically placing the sperm closer to the egg.

• An intrauterine insemination is done by using a small flexible catheter. • You will be positioned as if you were having a PAP test. A speculum is inserted into

the vagina and using a very thin flexible catheter, the washed sperm is drawn up into a syringe and gently guided through the cervical opening of the uterus and into the body of the uterus. Minimal cramping, as experienced during a pap test, may be experienced by some women.

• The procedure typically takes a few minutes. You will be asked to rest for about 5 to 10 minutes after the procedure before going back to home or work.

• You can resume your normal activities (including intercourse) unless counseled otherwise by your physician.

ADDING PROGESTERONE

(“CRINONE” GEL or “ENDOMETRIN” or PROGESTERONE SUPPOSITORIES)

• Progesterone supports the uterine lining and prepares a nourishing environment for the embryo

• Progesterone comes in various formulations including: vaginal gel applicators called “Crinone”; vaginal ovules called “Endometrin”; and natural progesterone vaginal suppositories

• Progesterone is added in to your cycle beginning the SECOND MORNING AFTER your IUI

• You will stay on progesterone until the onset of your next period (in the event that you are not pregnant) or until instructed to discontinue the medication at your pregnancy ultrasound appointment (approximately 4 to 5 weeks after your IUI)

• See “Helpful Hints for Progesterone”ADDENDUM at the end of this handbook for administration tips for these progesterone supplements.

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POST INSEMINATION FOLLOW-UP INSTRUCTIONS

• If you physician has specific instructions regarding follow-up for your cycle, these instructions will be reviewed with you.

• If you do not have a period by 16 days after your IUI, please call us at our office (excluding weekends) and leave a message on the clinical line (Farmington 860-679-2923; Hartford office 860- 525 8283 X 14. (Sometimes your period can be slightly delayed when using progesterone.) Include your name, spelling of your name, T00 # (or date of birth) and # at which we can reach you. We will call you back with instructions during scheduled business hours.

• If your pregnancy test is positive, you will receive instructions for follow-up blood work and we will schedule you for a pregnancy ultrasound for approximately 4 to 5 weeks after your IUI. This is a transvaginal ultrasound.

PART 4 TIME TO REVIEW THE TEACHING WEBSITE

• You are responsible for reviewing all assigned medication videos. See MEDICATION CHECKLIST ADDENDUM AT END of handbook

• To reach the website: o Log on to www.uconnfertility.com o Select “EDUCATION CENTER”

CLICK on “Village Pharmacy” icon Choose “The University of CT” for location log-on Select “Medication Information Pages” Select “Video Injection Lessons” on left hand side of screen Click on to each assigned medication(s)

OR • Click on Freedom Fertility Pharmacy icon and select your medication

and injection videos from the list

• Once you have reviewed both this teaching handbook AND the medication and injection videos, call teaching nurse and leave a message at:

Farmington Office 860-679 - 4467 Hartford Office 860-525 – 8283 X 14

• Your call will be returned WITHIN A FEW DAYS to complete a short phone

interview to verify your understanding of your current medication protocol; to answer any questions that you might have; and to receive your actual prescription.

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SUMMARY & KEY POINTS TO REMEMBER

1. Signed consents MUST be on your medical record before you begin to cycle. 2. Call the first day of your period to schedule your baseline ultrasound and blood

work as possible. See pages 3. Typically injectable medications will start on Cycle day #2 or # 3 4. You will be told when to start your injectable medications at your baseline

ultrsaound 5. Typically, you will be on these injectable medications for approximately 8 to 10 days 6. During this time your progress will be monitored with blood work and ultrasounds

until your follicles/eggs are matured 7. You will be told when to take the HCG “trigger” injection 8. You will be scheduled for an Intrauterine Insemination (IUI) typically 2 days after

the HCG “trigger”injection) 9. You will begin progesterone for uterine support the second morning after your

insemination

Please remember that we are here to assist you in any way that we can! Farmington Office # (860) 679-4580

Hartford Office # (860) 525-8283

ADDENDUMS HELPFUL HINTS WHEN TAKING INJECTABLE MEDICATIONS:

• Take the medications at approximately the same time of day (within 1 hour leeway).

Generally, evening medications are given between 6:00 PM to 8:00 PM. If your medication plan calls for injections twice a day, space them about 12 hours apart.

• Before injecting the medication, apply ice (wrapped in a cloth) for a few minutes to the area where the medication will be given to help minimize discomfort

• “Rotate” your injection sites for greater comfort • To avoid bruising at the injection site, apply pressure with a dry gauze pad for

approximately one minute to the site ABOUT MENOPUR INJECTIONS:

• Based upon our patients’ experience, you may find it easier to mix WITHOUT THE Q CAP. It is really a matter of preference. ATTACHED PLEASE SEE A VISUAL INSTRUCTION ADDENDUM FOR MIXING MENOPUR WITH A NEEDLE and SYRINGE (WITHOUT the “Q CAP” adaptor that comes in the box).

HELPFUL HINTS FOR USING CRINONE (PROGESTERONE) GEL:

• Insert Crinone ONCE A DAY in the morning into the vagina so that the gel will spread evenly throughout the day with normal daily activities. This will help minimize “clumping” of the gel in the vagina. Insert the applicator approximately one third of the depth of the applicator length into the vagina.

17 HELPFUL HINTS FOR ENDOMTRIN (PROGESTERONE) OVULES:

• The usual dose for endomterin ovules is 1 ovule TWICE A DAY (morning and evening) inserted into the vagina with the endometrin applicator.

HELPFUL HINTS FOR USING PROGESTERONE SUPPOSITORIES:

• Vaginal suppositories are inserted into the vagina TWICE A DAY – once in the morning and then again in the evening

• Insert your morning suppository approximately ½ hour before you get up out of bed • Insert suppository approximately 2/3 the length of your index finger

(Inserting the progesterone suppository too far into the vagina and up to the cervix may cause some “spotting” to occur.)

• Wear a mini-pad for greater comfort and to protect your clothing • Intercourse is permitted when on progesterone suppository therapy. However,

refrain from having intercourse for approximately ½ hour after inserting the suppository to allow it to melt.

IUI teaching class handbook 6.14.01 MMR revised 9.4.01 8.04.02;5.13.03; 4.16.04; 5.16.05; 8.15.05; 7.02.07; 11.08; 1.15.09; 4.09; 6.15.09; 8.12.09 MMR SD: 7.02.07; 4.09; 6.18.09 ; 8.12.09; 9.09

18 Patient_______________________ID#______________________

Medication Checklist (Revised 9/18/09)

____Cetrotide __0.25 mg __3mg AND “Subcutaneous injection” videos ____Ganirelix Acetate 250 mcg AND “Subcutaneous injection” videos ____Leuprolide Acetate(2 week kit) AND “Subcutaneous injection” videos ____Microdose Lupron (40mcg/0.1ml) AND “ Subcutaneous injection” videos ____Follistim pen Dose: ________________ ____Gonal-F pen Dose: ________________ ____Luveris vial (75IU) AND “Subcutaneous injection” videos ____Menopur (75IU) (without Q cap) AND “Subcutaneous injection videos

*See the addendum attached in packet for hints for mixing without the Q cap ____Repronex (75IU) (without Q cap) and Subcutaneous injection” videos ____Ovidrel 250 mcg AND “Subcutaneous injection” videos ____HCG (10,000IU) AND “ Subcutaneous injection” videos ____Leuprolide Acetate 0.5cc (1mg/0.2ccvial) AND “Subcutaneous injection” videos ____Progesterone in seame oil (50mg/cc) AND “Intramuscular injection” videos ____Progesterone in Olive oil (50mg/cc) AND “Intramuscular injection” videos ____Progesterone in ethyl Oleate (50mg/cc) AND “Intramuscular injection” videos ____Crinone 8% gel vaginal applicator ____Endometrin vag insert (100mg) ____Progesterone supp ___ 50mg ___ 100mg ____Vivelle dots (0.1mg) ____Bravelle (75IU) AND “Subcutaneous injection” videos Please review all medications and injection techniques checked above on the online video injection lesson at www.uconnfertility.com

• Next choose “Education Center” • Click on Village Fertility Pharmacy icon on the right hand side, click on the

link. (Location: University of Connecticut) • Click on “Medication Information pages” • Click on to each assigned medications and watch the medication video and

injection technique • OR can click on Freedom Fertility Pharmacy icon and bring up list of

medications and injections to review. • Both sites are in English and Spanish

Medication checklist rev 6.09 ; SD 6.09; 8.12.09; 9.09

Effective: 10.99 Revised SD 7.05; 7.07; 5.09 S:\IUI Online Packet\GONADOTROPINS.doc

GONADOTROPINS

*PLEASE DO NOT START MEDICATIONS UNTIL INSTRUCTED TO DO SO!! THIS IS THE BEGINNING OF YOUR PLAN AND IT WILL BE ADJUSTED AS YOU GO

DATE

CYCLE DAY LAB TEST

7 – 9 A.M. Mon-Fri

7:30-9 A.M. Saturday &

Sunday

U/S Schedule @ Farmington

(860) 679-4580 Hartford

(860) 525-8283

MEDICATION

NAME and DOSE

2

X

X

3

4

5

X

6

7

X

X

8

9

NOTE: After day 7, you will be instructed re: dosage and return dates.

You will need a 3cc/ml syringe with a 1 ½ inch needle attached, and a 30 gauge ½ inch needle

Remove the cap from the medication (powder) and wipe the top with an alcohol wipe

Remove the cap from the diluent (liquid) and wipe the top with an alcohol wipe

Remove syringe from the package

Tighten the needle on the syringe by

turning clockwise

Pull the plunger back to 1 cc filling the syringe with air. Use the top black line of the plunger as your marker. Remove needle cover by holding syringe sideways and pulling off cap.

Place bottle(liquid) on a flat surface. Place needle in center of diluent (liquid) bottle and push the air in the bottle.

You will need to keep holding the plunger down or it will come back up.

See next page before drawing out diluent(liquid).

Turn the bottle upside down and draw out 1 cc/ml of diluent (liquid).

Make sure the needle is below the level of the liquid or you will just get air. You need to have 1 cc/ml of the liquid. Remove the needle from the bottle and throw away diluent bottle.

Take out the medication bottle (powder).

Place on a flat surface.

Take the syringe that has the 1cc/ml of diluent and place needle in center of medication bottle.

Push the diluent into the powder the medication will mix quickly do not shake the bottle.

Turn the bottle upside down and make sure the needle is below the level of the fluid and draw out all of the liquid in the bottle. To get remaining liquid out you can pull back on the syringe plunger and withdraw the needle at the same time. Each bottle (powder) of menopur is 75 units if your dose is more you will now go to the next bottle of menopur(powder)

and put the liquid you have mixed already into that bottle and then remove as above. You can mix up to 4 powders to 1cc of diluent.

Carefully recap the needle by placing the cap on a flat surface and then inserting the needle into it. Remove needle by turning counter clockwise.

Take out the 30 gauge ½ inch needle remove from package.

Place on syringe turning clockwise until secure.

Hold needle sideways and pull the cap off of the needle .

Hold the syringe upright and tap gently to move all the air bubbles to the top of the syringe.

Gently and slowly push plunger to remove the air bubble. When you see a drop of liquid at the end of the needle stop. See the picture on the next page.

When you see a drop of liquid at the end of the needle stop pushing the plunger.

Make sure the needle does not touch anything before you inject.

Choose an area to inject the medication 2‐3 inches away from your belly button on either side or below .

Wipe area with alcohol wipe and let dry. Pinch area of skin between fingers.

Hold the needle like a pen or a dart.

Insert the needle completely with one quick motion.

Push in plunger to inject medication.

When medication is all in pull out needle with one smooth motion.

Hold gauze pad gently over injection area for a few minutes. It is not unusual to see a small drop of blood after the injection.

You can also view above medication on the online video injection lesson at www.fertilitycenter‐uconn.org next choose “Education Center” and you will see the link to Freedom Fertility Pharmacy on the right hand side, click on the link for injection training. Select the medication menopur and watch the medication video using the needle to mix the medication not the Q‐cap.

THE CENTER FOR ADVANCED REPRODUCTIVE SERVICES

CONSENT FOR SUPEROVULATION THERAPY

C014 Consent 14: Consent for Superovulation Therapy Version: 10/29/09

Female Name: ____________________________________ ID#_________________________________

Address: ____________________________________

____________________________________

____________________________________

I, the undersigned, request, authorize and consent to superovulation therapy by The Center for Advanced Reproductive

Services, PC (The Center), and as appropriate, its employees, contractors, and consultants and authorized agents.

Superovulation therapy is a technique used to increase the number of eggs matured within the ovaries in a cycle. Commonly

utilized medications include gonadotropins, hCG and GnRH analogs and antagonists. These medications are all given by

injection. In addition, in order to monitor the effects of these medications, multiple blood tests and ultrasound examinations

are required. There are various side effects and risks associated with the utilization of these medications, which are

described below.

Side effects: Women using these medications may experience various side effects. The most common ones are:

1) gastrointestinal symptoms including nausea, vomiting, diarrhea, abdominal cramps, bloating, 2) breast tenderness, 3)

mood changes, 4) allergic reactions involving flu-like symptoms including fever, chills, muscle aches, joint pains,

headaches or pain, rash, swelling and/or irritation at the site of injection, 5) abdominal bloating with associated pelvic

discomfort and 6) increased incidence of migraine headaches and 7) fatigue. Additional side effects associated with the

utilization of GnRH analogs are hot flashes and, rarely, transient impairment of short term memory. All of the above side

effects generally disappear after discontinuation of the medications.

Risks: Individuals using the above medications may also experience the following risks:

1. Ovarian hyperstimulation syndrome (OHSS): OHSS may include:

Cyst formation- The medications described above may result in large cysts forming on the ovaries. In the majority of cases,

ovarian cysts induced by gonadotropin stimulation disappear spontaneously requiring no intervention. In very rare

instances (less than 1% of cycles) these cysts could result in significant abdominal discomfort which could result in the

need for hospitalization for observation purposes. One of these cysts could rupture requiring emergency surgery to stop

bleeding. This could result in a need for blood transfusions and possible loss of one or both ovaries (0.1% of cycles).

Fluid shifts- Fluid shifts within the body may require hospitalization for observation and treatment (1%-3% of cycles). The

high levels of estrogen associated with the use of these medications may alter the way in which the body handles fluids.

More specifically, the blood vessels which supply the ovaries may become “leaky” resulting in the accumulation of

fluid within the abdominal cavity (ascites) or around the lungs (pleural effusion). This accumulation of fluid may result

in abdominal distension and discomfort with associated shortness of breath (due to the diaphragm being pushed upward

by the accumulation of fluid in the abdomen). In severe cases, removal of this fluid from the abdomen or from the space

around the lungs may be required using a small needle (0.5.% of cycles). The “leaky” vessels may also result in the

individual becoming dehydrated because the fluid is in the wrong place, i.e. in the abdomen instead of in the blood

vessels. Intravenous fluid administration may be required to maintain adequate blood flow to vital organs such as the

kidneys. Severe dehydration could result in irreversible organ failure or blood clot formation leading to a pulmonary

embolus (blood clots in the lung) or stroke (less than 0.1% of cycles). There are extremely rare reports in the literature

of death occurring as a result of complications of OHSS. OHSS is a risk which is inherent to ovulation induction

therapy; prevention cannot be guaranteed. At times, when monitoring shows that the risk of OHSS is unacceptably

high, a cycle may be canceled. Severe OHSS will rarely occur if hCG administration is withheld.

Consent for Superovulation Therapy

Page: 2

C014 Consent 14: Consent for Superovulation Therapy Version: 10/29/09

2. Multiple Pregnancy: Individuals utilizing superovulation therapy are at an increased risk for multiple pregnancy. The

risk of multiple pregnancy is also influenced by the patient’s age and diagnosis and therefore, the risk of multiple

pregnancy varies from patient to patient. The incidence of multiple pregnancy in individuals utilizing these medications

may be in excess of 30% of pregnancies with the incidence of triplets or more being in excess of 10% of pregnancies.

Multiple pregnancy often results in an increased risk of miscarriage, premature labor and premature birth. A premature

delivery may jeopardize the life and long term health of a child and may result in substantial costs both financially and

emotionally. Pregnancies with more than one baby in the uterus may also increase the occurrence of pregnancy related

medical complications for the mother such as high blood pressure and diabetes. Multiple pregnancy also increases the

likelihood that a cesarean section will be required. Parents raising children resulting from multiple births may be at

increased risk for major mood disorders such as anxiety and depression.

3. Ovarian cancer: Currently there are studies in the literature which suggest that women who use fertility medications are

at increased risk of developing cancer of the ovaries. Unfortunately, there are shortcomings of these studies, which

bring into question the validity of these findings. Infertility alone brings an increased risk of ovarian cancer. At this

point in time there is insufficient evidence to determine whether or not a relationship exists between the utilization of

fertility medications and an increased risk of ovarian cancer. Such a relationship may in fact exist but the current data

available is insufficient to definitely prove or disprove such a relationship. We cannot guarantee that a future link will

not be found.

4. Adnexal Torsion (Ovarian Twisting): Less than 1 percent (1%) of the time, the stimulated ovary can twist on itself,

cutting off its own blood supply. Surgery is required to untwist or even remove it.

In addition to the use of superovulation therapy, alternative therapies and options including adoption and no treatment have

been discussed with my physician.

We (I) expect this procedure to be performed with not less than the customary standard of care. We (I) understand the risks

and benefits as outlined, and further understand and agree that The Center shall be responsible only for acts of negligence

on its part and the part of its employees, contractors, consultants and authorized agents.

I have read the above information. I have had the opportunity to ask questions about superovulation and have had these

questions answered to my satisfaction. I understand that there are risks associated with the utilization of the above

medications and by signing below I accept these risks. I acknowledge that superovulation therapy is being performed with

my knowledge and consent.

_____/_____/_____ ___________________________________ __________________________________

Date Female Signature Witnessed By

Physician Signature:

This consent has been discussed with the patient.

_____/_____/_____ _______________________________________________ Date Physician Signature


CONSENT FOR ARTIFICIAL INSEMINATION INCLUDING INTRAUTERINE INSEMINATION (IUI) AND INTRACERVICAL INSEMINATION (ICI)

C017* Consent 17*: Consent to the Use of Artificial Insemination (IUI/ICI) without Notary Version: 05/05/05

Female Name:_______________________________ Female ID#________________________________ Partner Name:_________________________________ Partner ID#_________________________________ Address:____________________________________ ____________________________________ ____________________________________ We (I), the undersigned, request, authorize and consent to the performance of the procedure of artificial insemination, including either intrauterine or cervical insemination, by The Center for Advanced Reproductive Services, PC (The Center), and, as appropriate, its employees, contractors, consultants and authorized agents. Treatment with artificial insemination, including either intrauterine insemination (IUI) or, in some cases, intracervical insemination (ICI) may help a couple (or woman) achieve a pregnancy. The treatment involves three main steps: 1) obtaining a semen sample; 2) for IUI, preparation of the semen sample to isolate motile sperm; and 3) depositing the isolated motile sperm into the woman’s uterine cavity or cervix around the time of ovulation. IUI and ICI treatments involve several steps as outlined below. We (I) acknowledge and agree that we (I) cannot be guaranteed success at any or all of these steps and that if optimal results are not achieved at any step, it may be recommended that the treatment is stopped and the cycle canceled. A. Follicular Development: During a woman’s menstrual cycle, usually one mature follicle develops within the ovary,

resulting in the ovulation of a single egg. The growth of the ovarian follicle during the first half of a woman’s cycle is influenced by several hormones, including follicle stimulating hormone (FSH) and luteinizing hormone (LH) which are produced in the pituitary gland at the base of the brain. FSH is the main hormone that stimulates the growth of the follicle, which produces an estrogen hormone called estradiol. When the follicle is mature, a large amount of LH is released by the pituitary gland. This “LH surge” helps to mature the egg and leads to ovulation 36-40 hours after the initiation of the surge. The insemination is performed the day prior to ovulation, the day of ovulation, or soon after ovulation. This process may be monitored using home or office testing of the woman’s blood or urine or through the use of ultrasound or other methods determined by our (my) physician. We (I) acknowledge that in some cases this treatment may involve the use of superovulation therapy and that if this treatment is used that a separate consent form will be executed.

B. Preparation of the semen sample: On the day of the insemination, the male provides a semen sample. This sample may

be brought to the office, collected on site or may have been in storage in a frozen state and thawed for use in this treatment cycle. We (I) understand and agree that a picture ID is required for the patient or partner who brings the sample to the office or produces the sample on site. If donor samples are used they will be thawed on the day of insemination. The semen sample is then processed in the laboratory in preparation for the insemination process. This preparation may involve removal of seminal plasma (the liquid portion of the semen) and poorly motile sperm, concentration of the motile sperm or other evaluation of the sample. We (I) acknowledge that in some cases this treatment may involve the use of donor sperm and that if this treatment is used that a separate consent form will be executed.

C. Artificial Insemination--Intrauterine insemination (IUI) or Intracervical Insemination (ICI): The woman will return

to the office at the specified time, after the semen sample is dropped off. To perform the IUI, the woman is placed in the same position as if she were having a pelvic exam. A speculum is placed in the vagina to visualize the cervix. The sperm are loaded into a catheter, which is inserted through the cervical canal and into the uterine cavity. In cases where intracervical insemination is performed (ICI), the sample is placed in the cervix. The woman will lie down for a short time before leaving. Following the insemination normal activity can be resumed.

D. Treatment outcomes: The success rate (the delivery of a live born infant) of IUI/ICI varies and depends on many factors.

Some of the factors are: the age of the woman, the type of fertility medication used (if any); the diagnosis, the number of previous cycles of treatment and the quality of the semen sample. We (I) have discussed the success rates that apply in my case with my doctor. We (I) acknowledge and agree that the use of IUI versus ICI depends on individual circumstances that may only become apparent on the day of insemination and that that decision will be made by medical staff in consultation with us (me).

Consent to the Use of Artificial Insemination (IUI/ICI) Page: 2


E. Risks

1. Miscarriage: The risk of miscarriage in the general population is approximately 10-20%, but varies with age. Studies have not a shown a significant increase in the risk of miscarriage in women who conceive with IUI or ICI treatment. Most miscarriages are associated with lower abdominal cramping and bleeding, but do not necessarily require treatment. In some cases, however, complete removal of the pregnancy tissue must be accomplished by a surgical procedure. This procedure is usually performed under anesthesia in the operating room.

2. Tubal (ectopic) pregnancy: An ectopic pregnancy may result following this treatment. The majority of

ectopic pregnancies are present in the fallopian tube. The chance of a tubal pregnancy is greater in women with damaged tubes. If a woman has a tubal pregnancy, she may need surgical treatment, on occasion, which may involve the removal of the involved tube. Medical treatment with Methotrexate may be an option in selected cases.

3. Infection with an IUI/ICI is rare, but possible. Symptoms of an infection may include but are not limited to

persistent abdominal pain beginning within several days of insemination, fever and/or a vaginal discharge. This complication may be associated with, or cause, tubal disease and scarring. Antibiotic treatment may be required.

4. Other risks: Genetic abnormalities, structural abnormalities, mental retardation and other abnormalities

may occur following this treatment or pregnancies conceived naturally. The rate of congenital abnormalities (birth defects) in the general population is 2-3% and is not different in babies conceived with IUI treatment. Most infants who have been born following IUI/ICI treatment are normal.

F. Many factors may prevent this treatment from being successful. Some factors are known and some are unknown.

Examples of the known factors include but are not limited to, the following: 1. An ovarian follicle may not develop. 2. The male partner may be unable to produce a semen sample. 3. The passage of the catheter into the uterus or cervix may be technically difficult or impossible. 4. Even if the insemination is successfully performed, pregnancy may not result. 5. If a pregnancy is established, it may not develop normally or may miscarry.

6. Equipment failure, infection, technical problems, human errors and/or other unforeseen factors may result in injury to the patient or to loss or damage of the semen sample.

G. We (I) acknowledge that we (I) the undersigned, are voluntarily participating, individually and as a couple, in The Center

for Advanced Reproductive Service’s artificial insemination program (intrauterine insemination (IUI) and intracervical insemination (ICI) in order to conceive a child through this treatment.

H. We (I) understand and consent that if the individual providing the sperm sample for this procedure is not the sexually

intimate partner of the recipient, that we (I) have executed appropriate consents (for use of anonymous or identified sperm donors) and all involved parties will undergo all relevant federally mandated testing, screening and quarantine.

I. We (I) understand and consent that semen samples provided for this treatment are provided for the purpose of achieving a

pregnancy. We (I) agree and consent that the samples provided for this purpose are provided by the individual who has signed this consent where partner sperm is used. We (I) agree and consent that the individual providing the semen sample (for partner sperm), and who has signed this consent (for partner or donor sperm), will be contacted periodically by phone, mail and during visits to the Center to verify his continued participation and consent to this treatment, particularly when he does not deliver his samples to the Center himself.

J. We (I) understand, agree and acknowledge that we (I) are (am) not married to individuals who are not parties to this

informed consent. K. We (I) understand that should this cycle be unsuccessful, it may be determined that further treatment with IUI/ICI may not

be indicated. L. We (I) also understand that we are financially responsible for any medical expenses that are not covered by our insurance

policy.



M. We (I) expect this procedure to be performed with not less than the customary standard of care. We (I) understand the risks

and benefits as outlined, and further understand and agree that The Center shall be responsible only for acts of negligence on its part and the part of its employees, contractors, consultants and authorized agents.

N. We (I) have had the opportunity to review with and ask questions of our physician concerning alternative options to

Intrauterine Insemination, including adoption and no treatment in an effort to help us (me) overcome our (my) infertility. O. The nature of Artificial Insemination (including intrauterine insemination (IUI) and/or intracervical insemination (ICI))

has been explained to us (me), together with the known risks. We (I) understand the explanation that has been given to us (me). We (I) have had the opportunity to ask any questions we (I) might have and those questions have been answered to our (my) satisfaction. Any further questions we (I) might have may be addressed to The Center staff. We (I) acknowledge that Artificial Insemination (including intrauterine insemination (IUI) and/or intracervical insemination (ICI)) is being performed at our (my) request and with our (my) consent.

Date: _____/_____/_____ ________________________________ ____________________________

Female Signature Witnessed By

Date: _____/_____/_____ ________________________________ ____________________________

Partner Signature**** Witnessed By

*** If no partner, write N/A

Note: Each Signature Must Be Witnessed Separately THE CENTER FOR ADVANCED REPRODUCTIVE SERVICES MUST RECEIVE THIS CONSENT FORM PRIOR TO BEGINNING TREATMENT. Physician Signature: This consent has been discussed with the patient and her partner, if any. _____/_____/_____ _______________________________________________ Date Physician Signature



Patient Name (male)__________________________________________ SS#______________________________ (Or affix Label) Females Name_______________________________________ Date consent originally signed ________________ Primary MD_____________________ # to reach male partner ________________Home Phone _______________ Intrauterine Insemination: Periodic Documentation of Continued Male Partner Consent for Participation in Treatment (Use for Fresh Semen Samples Only) NOTES: • Document at least once every three months. • If male partner collects sample on site, document here quarterly, additional calls are not necessary. • If donor samples are used, document continued consent on the Donor Consent (15 or 16) only. • If frozen partner samples are used, document continued consent on Consent to Thaw Frozen Semen (5 or 5N). Date Phone Number

Called Individual Reached in

Person (State Name)

Continues to Consent to Procedure?

(Y/N)

Comments Person Making Call

(Signature)


CONSENT FOR ARTIFICIAL INSEMINATION INCLUDING INTRAUTERINE INSEMINATION (IUI) AND INTRACERVICAL INSEMINATION (ICI)

C017N Consent 17-N: Consent to the Use of Artificial Insemination (IUI/ICI) with Notary Version: 05/05/05

Female Name:_______________________________ Female ID#________________________________ Partner Name:_________________________________ Partner ID#_________________________________ Address:____________________________________ ____________________________________ ____________________________________ We (I), the undersigned, request, authorize and consent to the performance of the procedure of artificial insemination, including either intrauterine or cervical insemination, by The Center for Advanced Reproductive Services, PC (The Center), and, as appropriate, its employees, contractors, consultants and authorized agents. Treatment with artificial insemination, including either intrauterine insemination (IUI) or, in some cases, intracervical insemination (ICI) may help a couple (or woman) achieve a pregnancy. The treatment involves three main steps: 1) obtaining a semen sample; 2) for IUI, preparation of the semen sample to isolate motile sperm; and 3) depositing the isolated motile sperm into the woman’s uterine cavity or cervix around the time of ovulation. IUI and ICI treatments involve several steps as outlined below. We (I) acknowledge and agree that we (I) cannot be guaranteed success at any or all of these steps and that if optimal results are not achieved at any step, it may be recommended that the treatment is stopped and the cycle canceled. A. Follicular Development: During a woman’s menstrual cycle, usually one mature follicle develops within the ovary,

resulting in the ovulation of a single egg. The growth of the ovarian follicle during the first half of a woman’s cycle is influenced by several hormones, including follicle stimulating hormone (FSH) and luteinizing hormone (LH) which are produced in the pituitary gland at the base of the brain. FSH is the main hormone that stimulates the growth of the follicle, which produces an estrogen hormone called estradiol. When the follicle is mature, a large amount of LH is released by the pituitary gland. This “LH surge” helps to mature the egg and leads to ovulation 36-40 hours after the initiation of the surge. The insemination is performed the day prior to ovulation, the day of ovulation, or soon after ovulation. This process may be monitored using home or office testing of the woman’s blood or urine or through the use of ultrasound or other methods determined by our (my) physician. We (I) acknowledge that in some cases this treatment may involve the use of superovulation therapy and that if this treatment is used that a separate consent form will be executed.

B. Preparation of the semen sample: On the day of the insemination, the male provides a semen sample. This sample may

be brought to the office, collected on site or may have been in storage in a frozen state and thawed for use in this treatment cycle. We (I) understand and agree that a picture ID is required for the patient or partner who brings the sample to the office or produces the sample on site. If donor samples are used they will be thawed on the day of insemination. The semen sample is then processed in the laboratory in preparation for the insemination process. This preparation may involve removal of seminal plasma (the liquid portion of the semen) and poorly motile sperm, concentration of the motile sperm or other evaluation of the sample. We (I) acknowledge that in some cases this treatment may involve the use of donor sperm and that if this treatment is used that a separate consent form will be executed.

C. Artificial Insemination--Intrauterine insemination (IUI) or Intracervical Insemination (ICI): The woman will return

to the office at the specified time, after the semen sample is dropped off. To perform the IUI, the woman is placed in the same position as if she were having a pelvic exam. A speculum is placed in the vagina to visualize the cervix. The sperm are loaded into a catheter, which is inserted through the cervical canal and into the uterine cavity. In cases where intracervical insemination is performed (ICI), the sample is placed in the cervix. The woman will lie down for a short time before leaving. Following the insemination normal activity can be resumed.

D. Treatment outcomes: The success rate (the delivery of a live born infant) of IUI/ICI varies and depends on many factors.

Some of the factors are: the age of the woman, the type of fertility medication used (if any); the diagnosis, the number of previous cycles of treatment and the quality of the semen sample. We (I) have discussed the success rates that apply in my case with my doctor. We (I) acknowledge and agree that the use of IUI versus ICI depends on individual circumstances that may only become apparent on the day of insemination and that that decision will be made by medical staff in consultation with us (me).



E. Risks

1. Miscarriage: The risk of miscarriage in the general population is approximately 10-20%, but varies with age. Studies have not a shown a significant increase in the risk of miscarriage in women who conceive with IUI or ICI treatment. Most miscarriages are associated with lower abdominal cramping and bleeding, but do not necessarily require treatment. In some cases, however, complete removal of the pregnancy tissue must be accomplished by a surgical procedure. This procedure is usually performed under anesthesia in the operating room.

2. Tubal (ectopic) pregnancy: An ectopic pregnancy may result following this treatment. The majority of

ectopic pregnancies are present in the fallopian tube. The chance of a tubal pregnancy is greater in women with damaged tubes. If a woman has a tubal pregnancy, she may need surgical treatment, on occasion, which may involve the removal of the involved tube. Medical treatment with Methotrexate may be an option in selected cases.

3. Infection with an IUI/ICI is rare, but possible. Symptoms of an infection may include but are not limited to

persistent abdominal pain beginning within several days of insemination, fever and/or a vaginal discharge. This complication may be associated with, or cause, tubal disease and scarring. Antibiotic treatment may be required.

4. Other risks: Genetic abnormalities, structural abnormalities, mental retardation and other abnormalities

may occur following this treatment or pregnancies conceived naturally. The rate of congenital abnormalities (birth defects) in the general population is 2-3% and is not different in babies conceived with IUI treatment. Most infants who have been born following IUI/ICI treatment are normal.

F. Many factors may prevent this treatment from being successful. Some factors are known and some are unknown.

Examples of the known factors include but are not limited to, the following: 1. An ovarian follicle may not develop. 2. The male partner may be unable to produce a semen sample. 3. The passage of the catheter into the uterus or cervix may be technically difficult or impossible. 4. Even if the insemination is successfully performed, pregnancy may not result. 5. If a pregnancy is established, it may not develop normally or may miscarry.

6. Equipment failure, infection, technical problems, human errors and/or other unforeseen factors may result in injury to the patient or to loss or damage of the semen sample.

G. We (I) acknowledge that we (I) the undersigned, are voluntarily participating, individually and as a couple, in The Center

for Advanced Reproductive Service’s artificial insemination program (intrauterine insemination (IUI) and intracervical insemination (ICI) in order to conceive a child through this treatment.

H. We (I) understand and consent that if the individual providing the sperm sample for this procedure is not the sexually

intimate partner of the recipient, that we (I) have executed appropriate consents (for use of anonymous or identified sperm donors) and all involved parties will undergo all relevant federally mandated testing, screening and quarantine.

I. We (I) understand and consent that semen samples provided for this treatment are provided for the purpose of achieving a

pregnancy. We (I) agree and consent that the samples provided for this purpose are provided by the individual who has signed this consent where partner sperm is used. We (I) agree and consent that the individual providing the semen sample (for partner sperm), and who has signed this consent (for partner or donor sperm), will be contacted periodically by phone, mail and during visits to the Center to verify his continued participation and consent to this treatment, particularly when he does not deliver his samples to the Center himself.

J. We (I) understand, agree and acknowledge that we (I) are (am) not married to individuals who are not parties to this

informed consent. K. We (I) understand that should this cycle be unsuccessful, it may be determined that further treatment with IUI/ICI may not

be indicated. L. We (I) also understand that we are financially responsible for any medical expenses that are not covered by our insurance

policy.



M. We (I) expect this procedure to be performed with not less than the customary standard of care. We (I) understand the risks

and benefits as outlined, and further understand and agree that The Center shall be responsible only for acts of negligence on its part and the part of its employees, contractors, consultants and authorized agents.

N. We (I) have had the opportunity to review with and ask questions of our physician concerning alternative options to

Intrauterine Insemination, including adoption and no treatment in an effort to help us (me) overcome our (my) infertility. O. The nature of Artificial Insemination (including intrauterine insemination (IUI) and/or intracervical insemination (ICI))

has been explained to us (me), together with the known risks. We (I) understand the explanation that has been given to us (me). We (I) have had the opportunity to ask any questions we (I) might have and those questions have been answered to our (my) satisfaction. Any further questions we (I) might have may be addressed to The Center staff. We (I) acknowledge that Artificial Insemination (including intrauterine insemination (IUI) and/or intracervical insemination (ICI)) is being performed at our (my) request and with our (my) consent.

NOTE: If TWO signatures are required, BOTH signatures must be notarized. If both partners cannot appear before the notary at the same time, then the form can be duplicated and each partner can sign separately. _____/_____/_____ ____________________________________________________ Date Female Signature

_____/_____/_____ _____________________________________________________ Date Partner Signature*** If no partner, write N/A

Note: Notarization of BOTH signatures is required. State of Connecticut )

) County of _____________________ )

On ______________________________, before me, _____________________________________(Insert name of Notary), personally appeared ____________________________________________________________________(List only the names of individuals who actually appeared for this signature), personally known to me (or proved to me on the basis of satisfactory evidence) to be the person(s) whose name(s) is/are subscribed to the within instrument and acknowledged to me that he/she/they executed the same in his/her/their authorized capacity(ies), and that by his/her/their signature(s) on the instrument the person(s), or the entity upon behalf of which the person(s) acted, executed the instrument. WITNESS my hand and official seal. Signature ____________________________________ (Seal) THE CENTER FOR ADVANCED REPRODUCTIVE SERVICES MUST RECEIVE THIS CONSENT FORM PRIOR TO THE TRANSFER OF THE MATERIALS. THIS FORM MAY BE MAILED TO:

John Nulsen, MD, Program Director The Center for Advanced Reproductive Medicine Dowling South Building 263 Farmington Avenue Farmington, CT 06030 Tel: 860-679-4580

Physician Signature: This consent has been discussed with the patient and her partner, if any. _____/_____/_____ _______________________________________________ Date Physician Signature



Patient Name (male)__________________________________________ SS#______________________________ (Or affix Label) Females Name_______________________________________ Date consent originally signed ________________ Primary MD_____________________ # to reach male partner ________________Home # ___________________ Intrauterine Insemination: Periodic Documentation of Continued Male Partner Consent for Participation in Treatment (Use for Fresh Semen Samples Only) NOTES: • Document at least once every three months. • If male partner collects sample on site, document here quarterly, additional calls are not necessary. • If donor samples are used, document continued consent on the Donor Consent (15 or 16) only. • If frozen partner samples are used, document continued consent on Consent to Thaw Frozen Semen (5 or 5N). Date Phone Number

Called Individual Reached in

Person (State Name)

Continues to Consent to Procedure?

(Y/N)

Comments Person Making Call

(Signature)

On-Line Teaching Class Questionnaire Type of teaching class IVF ____ IUI _____ Have you had prior experience with giving yourself injections before reviewing the on-line information: Yes ______ No ______ On a scale of 1 to 10, with 1 being the lowest and 10 the highest score, please rank: BEFORE reviewing the on-line information: Your comfort level and understanding of your treatment plan BEFORE reviewing the information: 1 2 3 4 5 6 7 8 9 10 Your comfort level with giving injections BEFORE reviewing the information: 1 2 3 4 5 6 7 8 9 10 AFTER reviewing the on-line information: Your comfort level and understanding of your treatment plan AFTER reviewing information: 1 2 3 4 5 6 7 8 9 10 Your comfort level with giving injections AFTER reviewing information: 1 2 3 4 5 6 7 8 9 10 Did you feel that your questions were answered by reviewing the information? 1 2 3 4 5 6 7 8 9 10 Do you know what to do if you have an emergency or any questions regarding your plan? 1 2 3 4 5 6 7 8 9 10 Was there any information lacking in the information that you would have liked to see included? _______________________________________________________________________________________________________________________________________________ Signature OPTIONAL ________________ Date: __________________ On line teaching class questionnaire 3.09 mmr

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