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FSH Receptor Polymorphism p.N680S and Efficacy of FSH Therapy

NCT02349945 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2016-07-12

No results posted yet for this study

Summary

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.

Conditions

  • Male Infertility

Interventions

DRUG

follitropin alpha

All subjects included in the study will receive recombinant FSH therapy (follitropin alpha: Gonal-f 150 I.U. s.c. every other day for 12 weeks). Follow up: 12 further weeks after end of treatment. Previous studies included in the Cochrane meta-analysis used: hMG/hCG, 150 IU three times a week for 13 weeks; purified FSH, 150 IU/day for 12 weeks; rec hFSH, 150 IU/day for 12 weeks; rec hFSH, 100 IU on alternate days for 3 months. Therefore any dosage \> 100 IU on alternate days is eligible. The duration of treatment is based on the duration of one spermatogenetic cycle.

Sponsors & Collaborators

  • University of Roma La Sapienza

    collaborator OTHER

  • University of Halle Medical Faculty

    collaborator OTHER

  • Istituto Clinico Humanitas

    collaborator OTHER

  • University of Padova

    collaborator OTHER

  • University of Florence

    collaborator OTHER

  • Azienda USL Modena

    lead OTHER

Principal Investigators

  • Manuela Simoni, MD, PhD · Azienda USL Modena

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02349945 on ClinicalTrials.gov