None listed
Conditions
Brief summary
The favourable effect of local endometrial biopsy (LEB) in women undergoing embryo transfer or natural conception indicates that the LEB somehow enhances the endometrial receptivity in a group of women whose endometrium is otherwise not adequately receptive to an implanting embryo. As it is likely that poor endometrial receptivity is at least partly contributing to the experienced infertility in cases of polycystic ovarian syndrome (PCOS), LEB may also be beneficial for these couples. Unfortunately, research concerning the utility of LEB in couples with subfertility related to PCOS is sparse. We plan to address the current limitations by conducting a pragmatic, double-blind, randomised controlled trial of LEB in couples with subfertility related to PCOS.
Interventions
Women will undergo a single endometrial pipelle biopsy performed between days 1 and 12 of a stimulated cycle (clomiphene, letrozole or metformin).
Sponsors
Auckland District Health Board
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed