NCT02275169

FSH Treatment for Non-obstructive Azoospermic Patients

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Azienda Sanitaria Locale Bari · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Azoospermia

Interventions

Type	Name	Description
DRUG	Urofollitropin	Urofollitropin 75 IU 2 ampoules three times a week for three months
OTHER	Placebo	Placebo ampoules administered three times a week for three months

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-02-01
• Completion: 2016-11-01
• First posted: 2014-10-27
• Last updated: 2015-02-02