| Study name |
Pipelle for pregnancy (PIP) in couples with subfertility related to polycystic ovarian syndrome |
| Methods |
Randomised controlled trial |
| Participants |
Inclusion criteria:
Couples having regular unprotected sexual intercourse in a relationship where pregnancy is desired Women between 18 and 42 years of age at the time of randomisation Women who meet the criteria for polycystic ovary syndrome ‐ ≥ 2 of the following: (1) oligo‐ovulation 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 Having (a) 2 ovaries and 2 probably patent (functioning) fallopian tubes (confirmed by hysteroscopy or hysterosalpingography ‐ 1 tube may spasm/not free spill but must not be fully blocked); (b) ovulating on ovulation induction (OI) medication for ≤ 6 months (as HSG may not be recommended until failure to achieve pregnancy following ≥ 3 cycles of successful ovulation); or (c) previous intrauterine pregnancy and no subsequent surgery or ectopic pregnancy that may reduce tubal patency or ovarian function Body mass index (BMI) ≤ 35 kg/m² Negative cervical PAP smear within the last 3 years Willing to have regular sexual intercourse following the procedure in the month of the procedure and for 2 months following the procedure (or until pregnancy occurs). For women with polycystic ovarian syndrome, this includes 3 months of consecutive OI (unless pregnancy occurs) Willing to remain on OI medication for the study period (unless pregnancy occurs) ‐ clomiphene, letrozole, or metformin (or a combination). Doses may vary Male partner must have a normal semen analysis (volume ≥ 1.5 mL, progressive motility ≥ 32%, concentration ≥ 15 million/mL) or a total motile count ≥ 10 million
Exclusion criteria:
Having any disruptive instrumentation within the uterine cavity (e.g. hysteroscopy, hysterosalpingography, laparoscopy, surgically managed miscarriage, endometrial biopsy) within 3 months before Day 1 of the planned OI cycle, or planning to undergo a procedure involving disruptive instrumentation at any stage during the study Presence of any other cause of infertility, where spontaneous conception is unlikely (e.g. large fibroids) Recurrent miscarriage Previously entry into this study or participation in another trial in the last 30 days Any contraindication to endometrial biopsy or being pregnant and/or carrying a pregnancy to term
|
| Interventions |
Intervention group: a single endometrial pipelle biopsy performed between Day 1 and 12 of a stimulated cycle (clomiphene, letrozole, or metformin)
Control group: a single placebo procedure performed between Day 1 and 12 of a stimulated cycle (clomiphene, letrozole, or metformin) |
| Outcomes |
Live birth, miscarriage, ongoing pregnancy, clinical pregnancy, multiple pregnancy, pain during the procedure, bleeding following the procedure |
| Starting date |
June 2014 |
| Contact information |
Sarah Lensen; s.lensen@auckland.ac.nz |
| Notes |
ACTRN12614000657628
Confirmed ongoing by author correspondence in July 2020 |
