Trial | NCT02275169  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    200
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 Started
Feb 28
2015
Primary Completion
Feb 29
2016
Anticipated
Study Completion
Nov 30
2016
Anticipated
Last Update
Feb 02
2015
Estimate

Drug Urofollitropin

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

  • Other names: Fostimon

Other Placebo

Placebo ampoules administered three times a week for three months

Treated Experimental

Urofollitropin 150 IU ampoules three times a week for three months

Controls Placebo Comparator

Placebo ampoules three times a week for three months

Criteria 

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
No Results Posted