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.Methods:
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.Results:
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%).Conclusion:
Local endometrial injury for natural cycle conception in women with UI is not justified. Further RCT are warranted to prove or disprove this.