Significance of the FSH receptor polymorphism p.N680S for the efficacy of FSH therapy of idiopathic male infertility: a pharmacogenetic approach. - ND

Conditions: Idiopathic male infertility
MedDRA version: 9.1Level: HLGTClassification code 10014701
MedDRA version: 9.1Level: LLTClassification code 10021011

Registration Number: EUCTR2010-020240-35-IT

Lead Sponsor: AZIENDA OSPEDALIERA POLICLINICO DI MODENA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 100

Inclusion Criteria

Male idiopathic infertility. Age 20-50. Sperm DFI >15%, homozygosity for FSHR genotype at position 680 (either N or S). Normal serum FSH (<8 UI/l)and reproductive hormone levels. Normal ovulatory cycles in the female partner.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

zoospermia, endocrine disorders, genetic disorders (chromosome abnormalities, congenital bilateral absence of the vas deferens, microdeletions within the AZF regions of the Y chromosome), varicocele, cryptorchidism, infections, immunological infertility, and obstructive infertility. In the female partner, known etiologies of infertility such as tubal blockage, endocrine abnormalities, anatomical abnormalities, endometriosis or infections are an exclusion criterion for the respective male partner.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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).;Secondary Objective: pregnancy, semen parameters, serum levels of inhibin B and AMH.;Primary end point(s): Sperm DFI. Number of patients with an improvement in DFI > 60%

Secondary Outcome Measures