FSH Treatment for Non-obstructive Azoospermic Patients

January 30, 2015 updated by: Ettore Caroppo, Azienda Sanitaria Locale Bari

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated
Urofollitropin 150 IU ampoules three times a week for three months
Drug: Urofollitropin
Urofollitropin 75 IU 2 ampoules three times a week for three months
Other Names:
  • Fostimon
Placebo Comparator: Controls
Placebo ampoules three times a week for three months
Other: Placebo
Placebo ampoules administered three times a week for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm retrieval rate (SRR)
Time Frame: three months
testicular sperm retrieval rate after three months of urofollitropin treatment
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
IVF pregnancy rate
Time Frame: three to six months
three to six months
IVF implantation rate
Time Frame: three to six months
three to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Sanitaria Locale Bari

Collaborators

Minia University

Investigators

  • Study Director: Ettore Caroppo, MD, ASL Bari
  • Study Chair: Craig Niederberger, MD, University at Illinois at Chicago UIC College of Medicine
  • Principal Investigator: Alayman Hussein, MD, El Minia university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

February 2, 2015

Last Update Submitted That Met QC Criteria

January 30, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASLBari

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Azoospermia

Clinical Trials on Urofollitropin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe