Follicle-stimulating Hormone Treatment for Infertile Male Patients With Non-obstructive Azoospermia: a Multicenter Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 200
- Primary Endpoint
- Sperm retrieval rate (SRR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treated
Urofollitropin 150 IU ampoules three times a week for three months
Intervention: Urofollitropin (Drug)
Controls
Placebo ampoules three times a week for three months
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Sperm retrieval rate (SRR)
Time Frame: three months
testicular sperm retrieval rate after three months of urofollitropin treatment
Secondary Outcomes
- IVF pregnancy rate(three to six months)
- IVF implantation rate(three to six months)
Investigators
Ettore Caroppo
Dr
Azienda Sanitaria Locale Bari