FSH Treatment for Non-obstructive Azoospermic Patients
- Registration Number
- NCT02275169
- Lead Sponsor
- Azienda Sanitaria Locale Bari
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Controls Placebo Placebo ampoules three times a week for three months Treated Urofollitropin Urofollitropin 150 IU ampoules three times a week for three months
- Primary Outcome Measures
Name Time Method Sperm retrieval rate (SRR) three months testicular sperm retrieval rate after three months of urofollitropin treatment
- Secondary Outcome Measures
Name Time Method IVF pregnancy rate three to six months IVF implantation rate three to six months