Stopped: The DSMB recommended stopping the study because of concerns about the dismal recruitment, the drain on network resources, and the need for a study redesign.
The primary research hypothesis is that microsurgical varicocelectomy will result in an increase in live birth in infertile couples where the male partner has a palpable varicocele and an abnormal semen analysis in comparison to male partners who do not have microsurgical varicocelectomy. The secondary hypotheses include: 1. To assess whether up to 4 cycles of intrauterine insemination confers any additional increase in live birth rates compared to timed intercourse; 2. To examine spousal pregnancy rate as the secondary outcome; and 3. To study the effect of varicocelectomy in men with infertility, an abnormal semen analysis, and a palpable varicocele on * Testicular semen analysis parameters; * Serological measures of FSH, LH, total and free testosterone and * Measures of quality of life and sexual function in both partners.
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Number of Live Births After Eight Cycles of Infertility Treatment.
Timeframe: January 2009 to January 2012