Higher pregnancy rates with a simple method for fallopian tube sperm perfusion, using the cervical clamp double nut bivalve speculum in the treatment of unexplained infertility: a prospective randomized study.

The object of this study was to evaluate the efficacy of the newly developed cervical clamp double nut bivalve (DNB) speculum used for Fallopian tube sperm perfusion (FSP) with 4 ml of the inseminate, in comparison with standard intrauterine insemination (IUI) using a volume of 0.5 ml of the inseminate. Couples with unexplained infertility (n = 104), undergoing 202 cycles, were enrolled in this study. Cycles were assigned randomly to either IUI (group A, n = 92) or FSP + DNB speculum (group B, n = 110). Ovarian stimulation was achieved using three different ovarian stimulation protocols in both groups. The age and follicular development of the patients were similar in both groups. The serum hormonal measurements and the endometrial thickness was also similar on the day of human chorionic gonadotrophin (HCG) administration. The mean (+/-SD) number of motile spermatozoa inseminated was 44.83 +/- 16.57 x 10(6) in group A and 42.68 +/- 13.44 x 10(6) in group B. In group A (IUI). 11 clinical pregnancies (presence of gestational sac with heart beats) occurred (11.95% per cycle). In group B (FSP + DNB speculum) 29 clinical pregnancies occurred (26.36% per cycle). These differences were statistically significant (P < 0.001). The results of this study for the treatment of unexplained infertility indicate that this simple, well tolerated, inexpensive method of using the DNB speculum for FSP is more successful than standard IUI.

RCT Entities:   Population Interventions Outcomes