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

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.