FSH Receptor Polymorphism p.N680S and Efficacy of FSH Therapy

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.

Timeline

Start

2011-01

Primary completion

2014-12

Completion

2015-12

Drugs

Indications