Pipelle for pregnancy in couples with subfertility related to polycystic ovarian syndrome
- Conditions
- Polycystic ovarian syndromeReproductive Health and Childbirth - Fertility including in vitro fertilisation
- Registration Number
- ACTRN12614000657628
- Lead Sponsor
- Auckland District Health Board
- Brief Summary
1. Research question Does endometrial scratching improve the chance of a live birth in women with polycystic ovary syndrome (PCOS) undergoing ovulation induction and trying to conceive? 2. Background information It has been postulated that this procedure may benefit women with PCOS-related subfertility 3. Participant characteristics Participants met the Rotterdam criteria for diagnosis of PCOS, with at least two of the following: oligo- or anovulation, excess androgen activity (either biochemical or clinical) or polycystic ovaries on ultrasound scan. 4. Key results Eleven out of 58 (19%) of women in the scratch group and 14/59 (24%) of women in the control group had a live birth, which is not a statistically different result – but the results were imprecise and associated with some uncertainty. No evidence was found of differences in rates of secondary outcomes by group, but results were again imprecise. One miscarriage and one ectopic pregnancy occurred, both in the scratch group. There were no placental complications in either study group; however, there was one growth-restricted neonate in the scratch group. 5. Limitations The trial was stopped early due to the difficulty in recruiting participants, having enrolled only 117 of the revised aim of 176 subjects. The results are associated with wide confidence intervals and are consistent with scratch having no effect, a positive effect, or a negative effect.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 117
1. Couples having regular unprotected sexual intercourse in a relationship where pregnancy is desired
2. Women is between 18-42 years of age at the time of randomisation
3. Women who meet the criteria for PCOS, at least two of the following: 1) oligoovulation or anovulation (progesterone test) 2) excess androgen activity (elevated serum testosterone or clinical signs such as excess hair), 3) polycystic ovaries (as evidenced on ultrasound) – as per the Rotterdam criteria
4. Have either a) two ovaries and two probably patent fallopian tube (confirmed by hysteroscopy or HSG - one tube may spasm/not free spill). b) been ovulating on ovulation induction mediction for 6 months or less (as HSG may not be recommended until failure to achieve pregnancy following three or more cycles of successful ovulation), or c) A previous intrauterine pregnancy, and no subsequent surgery or ectopic pregnancy that may reduce tubal patency or ovarian function
5. A body mass index (BMI) less than or equal to 35
6. Have a negative cervical PAP smear within the last 3 years
7. Be willing to have regular sexual intercourse following the procedure in the month of the procedure, and for two months following the procedure (or until pregnancy occurs). For PCOS women, this includes three months of consecutive ovulation induction (unless pregnancy occurs)
8. Be willing to remain on ovulation induction medication for the study period (unless pregnancy occurs), either: clomiphene, letrozole or metformin (or a combination). Doses may vary.
9. Women who’s male partner has normal semen analysis (volume at least 1.5ml, progressive motility at least 32%, concentration at least 15million/ml) or a total motile count of equal to or more than 10 million
1. Have had any disruptive instrumentation within the uterine cavity (e.g. hysteroscopy, hysterosalpingogram, laparoscopy, surgically managed miscarriage or endometrial biopsy) within three months prior to day one of the planned ovulation induction cycle, or planning to undergo a procedure involving disruptive instrumentation at any stage during the study.
2. The presence of any other cause of infertility, where spontaneous conception is unlikely (e.g. large fibroids)
3. Recurrent miscarriage
4. Entered previously into this study or participation in another trial in the last 30 days
5. Any contraindication to endometrial biopsy or being pregnant and/or carrying a pregnancy to term
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ive birth - delivery of a live infant at least 20 weeks gestation [Approximately 9 months following the end of the study period]
- Secondary Outcome Measures
Name Time Method Clinical pregnancy - on ultrasound, the presence of at least one gestational sac [6 weeks following each ovulation induction cycle (3 consecutive ovulation induction cycles, unless pregnancy occurs)];Ongoing pregnancy - on ultrasound, the presence of at least one gestational sac and heartbeat [12 weeks following each ovulation induction cycle (3 consecutive ovulation induction cycles, unless pregnancy occurs)];Multiple pregnancy - on ultrasound, the presence of more than one heartbeat [6 weeks following each ovulation induction cycle (3 consecutive ovulation induction cycles, unless pregnancy occurs)];Adverse events - including miscarriage, ectopic pregnancy, pain or bleeding following the procedure, infection etc.[Bleeding and pain: on the day of the procedure or the following day<br>Infection: for 1 month following the procedure<br>Ectopic pregnancy and miscarriage: up to 20 weeks following the cycle in which pregnancy occurs]