Clinical Trial: Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled Trial of Clomiphene Citrate of Clomiphene Citrate in Hypoandrogenism and Azoospermia

Brief Summary: Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.

Detailed Summary: Hypogonadism (low testosterone level) is frequently observed in men presenting with non obstructive azoospermia. Controversy exists regarding the efficacy of preoperative hormonal manipulation in patients with hypogonadism. However, it is possible that hormonal therapy increases intra-testicular testosterone levels, and with a rise in serum testosterone, sperm production and surgical success with microTESE improve.
Sponsor: University of Illinois at Chicago

Current Primary Outcome:

  • Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE) [ Time Frame: After four months of clomiphene treatment ]
  • Epigenetic modifications [ Time Frame: After four months of clomiphene treatment ]


Original Primary Outcome: Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE) [ Time Frame: After four months of clomiphene treatment ]

Current Secondary Outcome: Testosterone levels and Bioavailable Testosterone levels [ Time Frame: After two weeks and four months with clomiphene treatment ]

Original Secondary Outcome: Same as current

Information By: University of Illinois at Chicago

Dates:
Date Received: May 9, 2014
Date Started: September 2015
Date Completion: October 2019
Last Updated: May 12, 2016
Last Verified: May 2016