NCT02349945 is a Phase 2/Phase 3 clinical trial of follitropin alpha in Male Infertility, sponsored by Azienda USL Modena.

Who is sponsoring NCT02349945?

NCT02349945 is sponsored by Azienda USL Modena.

What drugs are being tested in NCT02349945?

Interventions in NCT02349945: follitropin alpha.

What condition does NCT02349945 study?

NCT02349945 studies Male Infertility.

Is NCT02349945 still recruiting?

NCT02349945 is currently completed. Last updated 11 July 2016.

Last reviewed 2016-07-11 · How we verify

NCT02349945

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Significance of the FSH Receptor Polymorphism p.N680S for the Efficacy of FSH Therapy of Idiopathic Male Infertility: a Pharmacogenetic Approach

Completed Phase 2/Phase 3 Last updated 11 July 2016

What this trial tests

Phase 2/Phase 3 trial testing follitropin alpha in Male Infertility in 88 participants. Completed in 1 December 2015.

Timeline

1 January 2011

Primary endpoint
1 December 2014

1 December 2015

Quick facts

Lead sponsor	Azienda USL Modena
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	88
Start date	1 January 2011
Primary completion	1 December 2014
Estimated completion	1 December 2015
Sites	6 locations across Germany, Italy

Drugs / interventions tested

follitropin alpha — full drug profile →

Conditions studied

Male Infertility — all drugs for Male Infertility →

Sponsor

Azienda USL Modena — full company profile →

Who can join

Adults 20 to 50, male only, with Male Infertility. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sperm DFI
Time frame: "after 12 weeks"

Sponsor's own description

CONDITION: Idiopathic male infertility In men with idiopathic infertility, the sperm DNA fragmentation index (DFI) within 12 weeks of FSH therapy and 12 weeks follow-up improves depending on the FSHR genotype as assessed by the non-synonymous SNP rs6166 (wild type or p.N680S). This is a phase II b, multicenter, prospective, open label, one arm, clinical trial stratified according to the patient's genotype. INTERVENTION: FSH therapy (150 I.U. sc every other day for 12 weeks) in infertile men who are homozygous for the wild-type FSHR or the p.N680S allele of the FSHR. Duration of intervention per patient: 12 weeks Primary efficacy endpoint: Sperm DFI. Number of patients with an improvement in DFI \> 60% Key secondary endpoint(s): pregnancy, semen parameters, serum levels of inhibin B and AMH.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Male Infertility

Currently open trials in the same condition.

NCT07375238 — Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress · NA · recruiting
NCT07369362 — To Investigate if the Harvester® Improves Sperm Motility and Blastocyst Utilization (the Percent of Fertilized Eggs That · NA · active not recruiting
NCT06956287 — The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility · NA · recruiting
NCT06561451 — Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia · NA · recruiting
NCT07056400 — Trial to Improve Fertilization Rate and Embryo Development in Intracytoplasmic Sperm Injection (ICSI) Cycles · NA · active not recruiting

Other Azienda USL Modena trials

Trials by the same sponsor.

NCT05401383 — Implementation of Upper Gi Endoscopy Preparation: Fasting Versus Lumevis · unknown
NCT06316401 — Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia · completed
NCT04970173 — 1L-PEG-Asc Solution for Bowel Preparation in an "Open Access" Colonoscopy Booking System: Evaluation of Adverse Events · completed
NCT03551262 — Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers · NA · unknown
NCT03053115 — Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients · Phase 2, PHASE3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02349945 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Azienda USL Modena
Last refreshed: 11 July 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02349945.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing