Infertility: 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 thenewly developed cervical clamp double nut bivalve (DNB) speculumused for Fallopian tube sperm perfusion (FSP) with 4 ml of theinseminate, in comparison with standard intrauterine insemination(IUI) using a volume of 0.5 ml of the inseminate. Couples withunexplained infertility (n = 104), undergoing 202 cycles, wereenrolled in this study. Cycles were assigned randomly to eitherIUI (group A, n = 92) or FSP + DNB speculum^® (group B, n= 110). Ovarian stimulation was achieved using three differentovarian stimulation protocols in both groups. The age and folliculardevelopment of the patients were similar in both groups. Theserum hormonal measurements and the endometrial thickness wasalso similar on the day of human chorionic gonadotrophin (HCG)administration. The mean (± SD) number of motile spermatozoainseminated was 44.83 ± 16.57 x 10⁶ in group A and 42.68± 13.44 x 10⁶ in group B. In group A (IUI), 11 clinicalpregnancies (presence of gestational sac with heart beats) occurred(11.95% per cycle). In group B (FSP + DNB speculum^®) 29clinical pregnancies occurred (26.36% per cycle). These differenceswere statistically significant (P <0.001). The results ofthis study for the treatment of unexplained infertility indicatethat this simple, well tolerated, inexpensive method of usingthe DNB speculum for FSP is more successful than standard IUI.