Randomized controlled trial of the effect of endometrial injury on implantation and clinical pregnancy rates during the first ICSI cycle

Abstract

Objective: To assess whether endometrial injury in the cycle preceding controlled ovarian hyperstimulation during intracytoplasmic sperm injection (ICSI) improves the implantation and pregnancy rates.

Methods: Between January 1, 2016, and March 31, 2017, a randomized controlled trial was conducted at a center in Egypt among 300 women who met inclusion criteria (first ICSI cycle, aged <40 years, day-3 follicle-stimulating hormone <10 IU/L, normal serum prolactin, no uterine cavity abnormality). The women were randomly allocated using a web-based system to undergo endometrial scratch in the cycle preceding controlled ovarian hyperstimulation (n=150) or to a control group (n=150). Only data analysts were masked to group assignment. The primary outcomes were the implantation and clinical pregnancy rates at 14 days and 4 weeks after embryo transfer, respectively. Analyses were by intention to treat.

Results: The implantation rate was significantly higher in the endometrial scratch group (41.3% [90/218]) than in the control group (30.0% [63/210]; P<0.001). The clinical pregnancy rate was also significantly higher in the endometrial scratch group (44.2% [61/138]) than in the control group (30.4% [41/135]; P<0.001).

Conclusion: Endometrial injury in the cycle preceding the stimulation cycle improved implantation and pregnancy rates during ICSI. CLINICALTRIALS.GOV: NCT02660125.

Keywords: Clinical pregnancy; Endometrial injury; Implantation; Intracytoplasmic sperm injection.