Objective Abstract

References

Summary

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A randomized controlled trial of fallopian sperm perfusion compared with

standard intrauterine insemination for women with non-tubal infertility

C.M. Farquhar1,2, J. Brown1, N. Arroll1, D. Gupta2, C.V. Boothroyd3, Maha Al Bassam4, J. Moir5, and

N.P. Johnson6 1Faculty of Medicine and Health Sciences, The University of Auckland, Auckland, New Zealand 2Fertility Plus, Auckland District Health Board,

Auckland, New Zealand 3Assisted Conception Australia, Queensland, Australia 4Tawam Hospital, Al-Ain, United Arab Emirates 5Moir Medical, Queensland, Australia 6Repromed, Auckland, New Zealand.

Background

Stimulated Intrauterine insemination (SIUI) is commonly offered to couples with no tubal pathology. Usually ~0.5 ml of sperm suspension is inserted into the uterine cavity at the time of ovulation. Fertilisation typically occurs in the fallopian tube and concerns regarding the progressive decline of sperm along the fallopian tube. Fallopian tube sperm perfusion (FSP) was developed to increase sperm densities in the fallopian tubes. FSP involves injecting a higher volume of sperm suspension by using a catheter with an intrauterine balloon in an attempt to seal off the cervix to reduce efflux of sperm preparation to the vagina. The „NICE‟ guidelines recently commented that the evidence supported the use of fallopian sperm perfusion routinely. “Where intrauterine insemination is used to manage unexplained fertility problems, fallopian sperm perfusion for insemination (a large-volume solution, 4ml) should be offered because it improves pregnancy rates compared with standard insemination techniques”.1 A category A recommendation was given, indicating level 1 supporting evidence.

Aim

The aim of this randomized controlled trial was to evaluate whether FSP results in improved pregnancy and live birth rates when compared with SIUI, with or without ovulation stimulation.

Methods

A pragmatic, randomized (1:1), multicentre, parallel group, controlled trial of FSP and SIUI was undertaken. Women who were attending public or private fertility clinics and who were recommended to have IUI were invited to participate. Inclusion criteria: • Women aged 18–42 years old • Non-tubal infertility that was defined as

ovulatory according to a raised luteal phase serum progesterone level

• Proven patency of fallopian tubes • Normal semen analysis (either partner of

approved donor) In the IUI procedure the catheter was passed gently through the cervical canal high up into the uterus and the re-suspended specimen with a volume of 0.5 ml was slowly injected according to standard unit protocol. An atraumatic insemination catheter was used for the FSP procedure. The catheter was attached to a 5 ml syringe, and the dead space was filled with the suspension mixture. The catheter tip was passed gently through the cervical canal into the uterus and the catheter balloon was gently inflated. The specimen was slowly injected over 2 min, the balloon was deflated and the catheter was removed.

Wider implications of the findings

There was no evidence of an improvement in live birth rates with FSP compared with SIUI. There is no indication for the use of FSP in fertility clinics and fertility guidelines and protocols should be updated to reflect this. 1 National Collaborating Centre for Women's and Children's Health UK. 2004. NICE Clinical Guidelines: Assessment and Treatment for People with Fertility Problems, No. 11.). London: RCOG Press.

Demographics

SIUI (n=210) FSP (n=207)

Age (years) 33.67±4.87 (n=204)

34.23±4.62 (n=195)

BMI kg/m2 25.43±4.50 (n=192)

24.26±4.09 (n=184)

Median duration of infertility (months)

24 (IQR 9-42) (n=182)

24 (IQR 11-36) (n=168)

Parity ≥ 1 (%) 38 (18.0) 44 (21.4)

Main results and the role of chance:

There were no significant differences in live birth rates between the two groups with 27 (12.9%) in the SIUI group and 21 in the FSP group (10.1%) [Odds Ratio (OR) 1.31 (0.71, 2.39), P ¼ 0.48]. Two ectopic pregnancies were reported in the SIUI group and one was reported in the FSP group.

Limitations, reasons for caution

Different ovulation protocols were used in the different clinics. Approximately 10% of the cycles involved donor sperm and 5% of the cycles did not complete the assigned intervention.

SIUI

(n=210)

FSP

(n=207)

OR (95% CI)

Live birth rate per woman

27 (12.9%) 21 (10.1%) 1.31 (0.71, 2.39)

Clinical pregnancy rate

30 (14.3%) 24 (11.6%) 1.26 (0.71, 2.23)

Multiple pregnancy rate

4* 2** 1.69 (0.28, 10.13)

Pregnancy Loss •Ectopic •Miscarriage •OHSS

2 (1.0%) 9 (4.3%) 1 (0.5%)

1 (0.5%)

9(4.3%)

1 (0.5%)

−

0.71 (0.22, 2.30)

−

Figure 1. Flow of participants through the study.

Table 1. Baseline characteristics for women undergoing SIUI and FSP.

Table 2. Reproductive outcomes for women undergoing SIUI and FSP.