A randomized trial of local endometrial injury during ovulation induction cycles

Abstract

Objective: To investigate the effect of endometrial injury on pregnancy outcomes among infertile women taking clomifene citrate.

Methods: A prospective randomized trial was undertaken at an Egyptian hospital between January 26, 2015, and July 17, 2016. Eligible women (≥1 year primary/secondary/unexplained infertility, aged 20-35 years, day-2 follicle-stimulating hormone <12 IU/L, normal prolactin/thyroid function/uterine cavity, ≥1 patent tube, male partner with normal semen count and motility, 3 cycles of clomifene citrate without success) were randomly allocated (1:1) using computer-generated numbers into intervention (received endometrial injury on cycle day 15-24) or control groups (sham procedure). Women began ovulation induction on days 3-5 of the following cycle. Participants and investigators were not masked to group assignment. The primary outcomes were clinical pregnancy, spontaneous abortion, and multiple pregnancy rates. Women who completed follow-up were included in analyses.

Results: The intervention group included 52 women and the control group 53 women. The clinical pregnancy rate was significantly higher in the intervention group (37% [n=19]) than in the control group (13% [n=7]; P=0.006). No differences between the intervention and control groups were noted for spontaneous abortion rate (11% [2/19] vs 29% [2/7]; P=0.287) or multiple pregnancy rate (11% [2/19] vs 14% [1/7]; P=0.790). No adverse effects were reported.

Conclusion: Endometrial injury before ovulation induction could improve chances of pregnancy and its outcomes. CLINICALTRIALS.GOV: NCT02345837.

Keywords: Endometrial injury; Infertility treatment; Ovulation induction; Pipelle biopsy sampling; Pregnancy outcomes.