FSH Treatment for Non-obstructive Azoospermic Patients

Azienda Sanitaria Locale Bari200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

200

Conditions

Azoospermia

Interventions

UrofollitropinDRUG

Urofollitropin 75 IU 2 ampoules three times a week for three months

PlaceboOTHER

Placebo ampoules administered three times a week for three months

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Azoospermia; * testis longitudinal axis less than 4.5 cm; * serum follicle-stimulating hormone greater than 7.6 IU/L Exclusion Criteria: * History of testicular biopsy, * malignancy, * varicocele, * hyperprolactinemia, * thyroid disfunction, * chemotherapy, * radiotherapy