FSH Treatment for Non-obstructive Azoospermic Patients

Azienda Sanitaria Locale Bari

Status and phase: Unknown; Phase 3

Conditions: Azoospermia

Treatments: Other: Placebo; Drug: Urofollitropin

Study type: Interventional

Funder types: Other

Identifiers

NCT02275169

ASLBari

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Treated

Experimental group

Description:

Urofollitropin 150 IU ampoules three times a week for three months

Treatment:

Drug: Urofollitropin

Controls

Placebo Comparator group

Description:

Placebo ampoules three times a week for three months

Treatment:

Other: Placebo