FSH Receptor Polymorphism p.N680S and Efficacy of FSH Therapy
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Azienda USL Modena
Collaborators:
Istituto Clinico Humanitas University of Florence University of Halle Medical Faculty University of Padova University of Roma La Sapienza