Clinical Trial: FSH Treatment for Non-obstructive Azoospermic Patients

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Follicle-stimulating Hormone Treatment for Infertile Male Patients With Non-obstructive Azoospermia: a Multicenter Randomized Clinical Trial

Brief Summary: Aim of the study is to evaluate the effect of highly purified human follicle-stimulating hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from infertile male patients with non-obstructive azoospermia of unknown origin.

Detailed Summary: Preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with NOA, but no RCT are available in the field. This randomized placebo-controlled clinical trial sought to evaluate whether the testicular sperm retrieval rate could result higher in NOA patients treated with follicle-stimulating hormone compared to placebo-treated NOA subjects.
Sponsor: Azienda Sanitaria Locale Bari

Current Primary Outcome: Sperm retrieval rate (SRR) [ Time Frame: three months ]

testicular sperm retrieval rate after three months of urofollitropin treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • IVF pregnancy rate [ Time Frame: three to six months ]
  • IVF implantation rate [ Time Frame: three to six months ]


Original Secondary Outcome: Same as current

Information By: Azienda Sanitaria Locale Bari

Dates:
Date Received: October 21, 2014
Date Started: February 2015
Date Completion: November 2016
Last Updated: January 30, 2015
Last Verified: January 2015