Pipelle for Pregnancy in Polycystic Ovarian Syndrome (PIP-PCOS)

Study design

The PIP-PCOS study is a double-blind, randomised controlled trial in couples with subfertility related to polycystic ovarian syndrome (PCOS) who are on ovulation induction medication and trying to get pregnant.

Eligible women who consent to participate in the trial will be randomly allocated to either

  1. An endometrial pipelle sampling procedure
  2. A placebo procedure

Participants will not be told which group they have been allocated to until the end of the trial. All participants will be scheduled for a 20 minute appointment at the fertility clinic. At the time of the visit, the PIP study doctor will open the randomisation code and then will perform the procedure stated. There is a 50/50 chance of being allocated to each arm. The allocation occurs completely at random and participants are not able to chose their allocation or change the allocation.

Participants will be asked to have regular sexual intercourse for 3 ovulation induction cycles following the procedure, and to record their menstrual cycles and sexual activity in a supplied diary.

Eligibility criteria

Couples are eligible for the PIP-PCOS study if:

  1. Women is 42 years of age or younger at the time of randomisation
  2. Women who are diagnosed with polycystic ovarian syndrome (at least two of the below):
    • No ovulation or infrequent ovulation/menstruation
    • excess androgen activity (elevated serum testosterone or clinical signs such as excess hair)
    • polycystic ovaries (as evidenced on ultrasound)
  3. Male partner has had a normal semen analysis in last 5 years
  4. Women has at least one functioning fallopian tube and at least one ovary
  5. Have a body mass index (BMI) </= 35 kg/m2
  6. Have a normal cervical PAP smear result within the last 3 years
  7. Are willing to have regular sexual intercourse following the procedure in the month of the procedure, and for two months following the procedure and to record this information in a supplied diary
  8. Are willing to remain on the same type of ovulation induction medication for the three months of the study (doses may vary)
  9. There is no other cause of infertility present (e.g. large fibroid)
  10. Have not had any of the following within 3 months of joining the PIP-PCOS study:
    • hysteroscopy
    • hysterosalpingogram (HSG)
    • endometrial biopsy
    • laparoscopy
    • surgically managed miscarriage
  11. Have not participated in another trial in the last 30 days