Pipelle for Pregnancy in Unexplained Infertility (PIP-UE)

Study design

The PIP-UE study is a double-blind, randomised controlled trial in couples with unexplained infertility who are 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 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 their allocation.

Participants will be asked to have regular sexual intercourse for 3 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-UE study if:

  1. Women is 42 years of age or younger at the time of randomisation
  2. Women who are diagnosed with unexplained infertility:
    • unsuccessfully trying to conceive for at least 12 months
    • normal ovulation (21-42 day menstrual cycles with variation <8 days and luteal phase progesterone test)
    • normal semen analysis in last 5 years
  3. Have at least one functioning fallopian tube and at least one ovary
  4. Have a body mass index (BMI) </= 35 kg/m2
  5. Have a normal cervical PAP smear result within the last 3 years
  6. 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
  7. Have not had any of the following within 3 months of joining the PIP-UE study:
    • hysteroscopy
    • hysterosalpingogram (HSG)
    • endometrial biopsy
    • laparoscopy
    • surgically managed miscarriage
  8. Have not participated in another trial in the last 30 days