RCT TO STUDY THE EFFECT OF VAGINAL SILDENAFIL IN IMPROVING ART OUTCOME IN WOMEN WITH RECURRENT IMPLANTATION FAILURE UNDERGOING IVF-ICSI CYCLES

Abstract

The objective of this study was to evaluate the effect of vaginal sildenafil in improving the IVF-ICSI outcome in patients with Recurrent implantation failure due to thin endometrium undergoing IVF-ICSI cycles. 52 patients with Recurrent implantation failure and a thin endometrium (Endometrial-thickness less than 7mm) were randomized into two groups. Group A patients self-administered sildenafil citrate vaginal suppositories 25mg four times a day, starting from the fifth day of menstrual cycle till the embryo transfer day. Group-B patients did not receive vaginal sildenafil. Endometrial thickness and spiral artery RI & PI were assessed using trans-vaginal spectral ultrasound Doppler in the sub-endometrial zone before embryo-transfer in both the groups of patients. The primary outcomes measured were the maximum endometrial thickness prior to embryo transfer, implantation rate and the clinical pregnancy rate. The secondary outcome measured was the abortion rate. Statistically significant improvement of endometrial thickness and endometrial blood flow with significant reduction of RI & PI were detected in Group-A patients (Study group). Implantation rate and pregnancy rate were also significantly higher in patients in the sildenafil group as compared to patients in the non-sildenafil group. (14% vs 6%) & (23% vs 11%) respectively. Abortion rate was also higher in non-sildenafil group. Vaginal sildenafil may conceivably improve Clinical pregnancy rates in thin endometrium patients suffering from recurrent implantation failure in IVF-ICSI cycles. Further randomized clinical trials using vaginal sildenafil with a higher sample size are recommended.