| Study name |
Pipelle for pregnancy (PIP) in couples with subfertility related to unexplained infertility |
| 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 diagnosed with unexplained infertility: normal ovulation (21‐ to 35‐day menstrual cycles with variation < 8 days and luteal phase progesterone test), normal semen analysis (progressive motility ≥ 32%, volume ≥ 1.5 mL, conc. ≥ 15 million/mL) or total motile count ≥ 10 million Havin either (a) at 2 ovaries and 2 probably patent (functioning) fallopian tubes (confirmed by hysteroscopy or hysterosalpingography (HSG)) or (b) a previous intrauterine pregnancy, and no subsequent surgery or ectopic pregnancy that may reduce tubal patency or ovarian function Body mass index ≤ 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)
Exclusion criteria:
Having had any disruptive instrumentation within the uterine cavity (e.g. hysteroscopy, HSG, laparoscopy, surgically managed miscarriage, endometrial biopsy) within 3 months before Day 1 of the first study menstrual cycle, or planning to undergo a procedure involving disruptive instrumentation at any stage during the study Entered previously into this study or participated in another trial in the last 30 days Any contraindication to endometrial biopsy, or pregnant or carrying a pregnancy to term, or both
|
| Interventions |
Intervention group: a single endometrial pipelle biopsy performed between Day 1 and 12 of a menstrual cycle
Control group: a single placebo procedure performed between Day 1 and 12 of a menstrual cycle |
| 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 |
ACTRN12614000656639
Confirmed as ongoing by author correspondence in July 2020 |
