Hysteroscopic-guided local endometrial injury does not improve natural cycle pregnancy rate in women with unexplained infertility: Randomized controlled trial.

Abstract

To evaluate the efficacy of a hysteroscopic site-specific local endometrial injury (LEI) in a group of women with unexplained infertility (UI) undergoing expectant management with no fertility treatment versus no intervention. This open-label, randomized controlled trial (RCT) was conducted between June 2013 and July 2015. Hysteroscopic site-specific LEI was determined by patient identification number, and 120 women were included. Eligible participants were randomly assigned to receive either a single, site-specific LEI guided by hysteroscopy (study group, n = 60) or no intervention (control group, n = 60). Natural cycle folliculometry and timed intercourse were carried out for all participants for 3 months. Successful clinical pregnancy confirmed on ultrasound was the primary outcome measure, and first trimester miscarriage rate was the secondary outcome. After identification, baseline clinical demographics were similar in the two groups. No statistically significant differences were noted in cumulative pregnancy rates in women with LEI compared with those without (16.7% and 11.7 %, respectively; OR, 2.83; 95%CI: 1.07-7.48; P = 0.4). One first trimester miscarriage was reported in the control group (14.3%). Local endometrial injury for natural cycle conception in women with UI is not justified. Further RCT are warranted to prove or disprove this.