from idea to execution how to start an egg bank. relevant disclosures shareholder/co-founder –...
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F R O M I D E A T O E X E C U T I O N
HOW TO START AN EGG BANK
RELEVANT DISCLOSURES
Shareholder/Co-founder – Donor Egg Bank USA, LLC
OBJECTIVES
Understand the current cultural climate impacting women’s decisions to freeze
Provoke thought regarding variables to successful egg banking – autologous & donor
Identify different models for third party egg banking
Discuss methods of execution Review future trends and lessons learned
IDEA TO EXECUTION
Identify the market Manage quality nuances
Lab Clinical Set realistic expectations
Put operational logistics in place Consents & Legal documents
Determine the right model
It seemed so simple…
FROZEN EGG BASIC MODEL
Frozen eggs decouple the traditional process of stimulation followed by transfer.
Frozen Egg Cycle
Stimulation Cycle
Storage or Coordinati
on Fee
Transfer Cycle
THE FROZEN EGG MARKET
CULTURAL SHIFTS DRIVE FROZEN EGG BANKING
900% increase in women >35 having their first child since 1970
35% increase among women ages 40-44
Autologous: More women freezing eggs as “insurance against an uncertain future.”
Third Party: US Foreign Adoptions are at the lowest level since 1982 (6,441 adopted in 2014 vs. 23,000
in 2004) Source: US State Department Report to Congress, April 1, 2015
Source: May 2014; www.cdc.gov
REASONS FOR NOT HAVING CHILDREN EARLIER
Fertil Steril. 2013;100(5): 1343-49
Lack of Partner Professional Reasons
Financial Reasons Too Large of a Commitment
Other0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
88%
24%
15% 15%
8%
Survey of 500 women after completionof 1 egg freezing cycle
WHY DO WOMEN FREEZE THEIR EGGS?
Source: Fertil Steril. 2013;100(3): S24
Rank in order of importance:(some women ranked more than one option)
HOW WOMEN FIRST LEARNED ABOUT EGG FREEZING
Source: Fertil Steril. 2013;100(5): 1343-49
Friend
OB/GYN
TV/Magazine
Internet
Medical Doctor
Other
0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0%
50.5%
25.3%
23.6%
18.7%
12.1%
10.4%
QUALITY
QUALITY FACTORS
1. Oocyte potential 2. Oocyte stimulation3. Freeze/Thaw Technician4. Lab environment5. Device Carrier6. Storage and handling7. Endometrial prep8. Sperm quality9. Media culture10.Transfer technique
QUALITY CONSISTENCY
Freeze Tech #Ongoing/ET
#Ongoing/ET
2013 2014
S-F 26 27% 6 60%
TB-S 26 39% 34 55%JL-S 113 51% 16 50%K-R 22 41% 2 50%JG-S 52 56% 53 49%K-S 28 61% 45 44%
PD-S 22 59% 42 43%T-C 7 57% 69 40%B-B 27 41% 9 38%B-F 18 22% 9 25%
FREEZE VS THAW SKILLSET
© 2014 Pro Baseball Insider, LLC (PBI)
FREEZE VS THAW DIFFERENTIALS
Tech #Freeze
#Thaw
On-going/ET Ongoing/ET
S-A 12 33% 8 75%
TO-C 62 40% 8 50%
R-F 9 22% 19 43%
S-F 5 60% 15 60%
M-R 43 63% 7 27%
C-R 0 n/a 21 45%
T-R 10 60% 14 50%
N-RS 10 70% 4 0%
J-S 53 49% 12 50%
L-S 22 50% 20 35%
HOW DO YOU KNOW?
High enough “N” to see trend Comparison data
Between embryologists Multiple cohort thaws
Track everything – device, # of eggs thawed, media, storage, etc. Mechanism to monitor/analyze
Clinical Impact
Creative Commons Licensing
OTHER LAB CONSIDERATIONS
Who on the embryology team? Vit: Best hands, best adherence to protocol Thaw: Highly skilled, best troubleshooter
Set-up for egg vit vs. thaw Lab environment and set up Thermometer Stop watch (count up function) Vit/thaw products/devices
Staffing on day of vit/thaw Practice & review of protocol Egg storage
DEVICE CARRIER
Open Systems Cryotop Cryolock Cryotec Etc.
Closed Systems CryoTip Rapid-I Etc.
OPERATIONAL LOGISTICS
Freezing –of eggs sets of 1, 2, 4 Thaw protocols
Thaw until… Set number of eggs – ie. 6
Guarantee Survival/Embryo/Blast $$ value on autologous
OPERATIONAL LOGISTICS
Consents specific to the process cryo-preserved eggs to freeze cryo-preserved eggs to thaw & make embryos
Disposition Autologous
Eggs not needed Premature death Donation Research
Third Party Look backs –eggs not usable Questionable quality – identifiable track record Unselectability Donor updates over time Abandoned eggs – returnable? Capital loss from poor quality or lookbacks (recalls)
REALISTIC EXPECTATIONS
ASRM Guidelines - “There are not sufficient data to recommend oocyte cryopreservation for the sole purpose of circumventing reproductive aging in healthy women. “ ASRM/SART Practice Committees, Mature oocyte cryopreservation: a guideline, Fertil Steril. 2013;99:37-43
Egg freezing parties, Google/Facebook, newest “graduation gift”, 401K
How fear fuels the business of egg freezing, Danielle Paquette, Washington Post, March 6, 2015
Slogan “Lean in. But freeze first.”
EGG THAW OUTCOMES
IR= Implantation Rate
Courtesy of Shady Grove Fertility1.877.411.9292
THIRD PARTY MODELS
Independent egg bank Shared cycles Greater risk - $$ and unused inventory
Network – open/closed egg banking Limits risk Increases interdependency Minimizes unused inventory
Agency driven models Liability?
LESSONS LEARNED
More challenging than originally thought Lab environments and embryologists are not equally
skilled to freeze/thaw eggs Quality tracking is key – you can’t assume all is well. Logistics and infrastructure is essential Technology continues to evolve and best practices are
becoming known Economically beneficial and efficient use of egg
resources
Egg banking is the newest frontier in ART and much remains unexplored