A single-blind, randomised controlled trial assessing the effect of endometrial pipelle biopsy vs. sham biopsy on live birth rate in couples with unexplained infertility

Auckland District Health Board0 个研究点目标入组 117 人开始时间: 2014年6月24日最近更新: 2022年5月23日

试验速览

Research question To investigate whether endometrial scratching increases the chance of live birth in women with unexplained infertility attempting to conceive without assisted reproductive technology. 2. Background information Several studies showed a possible beneficial effect of endometrial scratching for unassisted conception in women with unexplained infertility. However, recent pooled results from randomised controlled trials did not suggest evidence of benefit from this procedure. 3. Participant characteristics Inclusion criteria: age less than 42 years at the time of randomisation, a body mass index (BMI) less than 35 kg/m2, and a diagnosis of unexplained infertility. Women were required to be in a relationship where they were able to have regular unprotected sexual intercourse with the intention of conceiving. 4. Key results The live birth rate was 7% (7 of 107) in the control group and 9% (10 of 113) in the endometrial-scratch group, which was similar in each group. We did not detect any differences between the groups in the rates of clinical pregnancy, ongoing pregnancy, and miscarriage. 5. Limitations We terminated the study early and revised the sample size due to slow recruitment. Our findings are consistent with previous meta analyses, which showed no differences in live birth rates. Our results should be interpreted with caution due to the wide confidence intervals, meaning the possibility of no effect as well as large effects in either direction.

•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 are diagnosed with unexplained infertility: normal ovulation (21-35 day menstrual cycles with variation <8 days and luteal phase progesterone test), normal semen analysis (progressive motility atleast 32%, volume at least 1.5ml, conc. at least 15million/ml) or total motile count equal to or more than 10 million
•4. Have either a) at two ovaries and two probably patent fallopian tubes (confirmed by hysteroscopy or HSG) or b) 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) of equal to or less than 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)

•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 first study menstrual cycle, or planning to undergo a procedure involving disruptive instrumentation at any stage during the study.
•2. Entered previously into this study or participation in another trial in the last 30 days
•3. Any contraindication to endometrial biopsy or being pregnant and/or carrying a pregnancy to term

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