FSH Treatment for Non-obstructive Azoospermic Patients

NCT ID: NCT02275169

Last Updated: 2015-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Azoospermia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treated

Urofollitropin 150 IU ampoules three times a week for three months

Group Type EXPERIMENTAL

Urofollitropin

Intervention Type DRUG

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

Controls

Placebo ampoules three times a week for three months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo ampoules administered three times a week for three months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Urofollitropin

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

Intervention Type DRUG

Placebo

Placebo ampoules administered three times a week for three months

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fostimon

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Minia University

OTHER

Sponsor Role collaborator

Azienda Sanitaria Locale Bari

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ettore Caroppo

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ettore Caroppo, MD

Role: STUDY_DIRECTOR

ASL Bari

Craig Niederberger, MD

Role: STUDY_CHAIR

University at Illinois at Chicago UIC College of Medicine

Alayman Hussein, MD

Role: PRINCIPAL_INVESTIGATOR

El Minia University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ettore Caroppo, MD

Role: CONTACT

+393479103660

Craig Niederberger, MD

Role: CONTACT

3129969330

References

Explore related publications, articles, or registry entries linked to this study.

Sussman EM, Chudnovsky A, Niederberger CS. Hormonal evaluation of the infertile male: has it evolved? Urol Clin North Am. 2008 May;35(2):147-55, vii. doi: 10.1016/j.ucl.2008.01.010.

Reference Type BACKGROUND
PMID: 18423236 (View on PubMed)

Schoor RA, Elhanbly S, Niederberger CS, Ross LS. The role of testicular biopsy in the modern management of male infertility. J Urol. 2002 Jan;167(1):197-200.

Reference Type BACKGROUND
PMID: 11743304 (View on PubMed)

Caroppo E, Niederberger C, Vizziello GM, D'Amato G. Recombinant human follicle-stimulating hormone as a pretreatment for idiopathic oligoasthenoteratozoospermic patients undergoing intracytoplasmic sperm injection. Fertil Steril. 2003 Dec;80(6):1398-403. doi: 10.1016/s0015-0282(03)02202-7.

Reference Type RESULT
PMID: 14667875 (View on PubMed)

Kato Y, Shiraishi K, Matsuyama H. Expression of testicular androgen receptor in non-obstructive azoospermia and its change after hormonal therapy. Andrology. 2014 Sep;2(5):734-40. doi: 10.1111/j.2047-2927.2014.00240.x. Epub 2014 Jun 12.

Reference Type RESULT
PMID: 24919724 (View on PubMed)

Hussein A, Ozgok Y, Ross L, Rao P, Niederberger C. Optimization of spermatogenesis-regulating hormones in patients with non-obstructive azoospermia and its impact on sperm retrieval: a multicentre study. BJU Int. 2013 Mar;111(3 Pt B):E110-4. doi: 10.1111/j.1464-410X.2012.11485.x. Epub 2012 Sep 7.

Reference Type RESULT
PMID: 22958644 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ASLBari

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hormonal Stimulation of Spermatogenesis
NCT05483621 COMPLETED PHASE1
Contraception in Normal and Subnormal Men
NCT00167141 TERMINATED PHASE2