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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020240-35-IT

Enrollment

100

Registered

2010-07-15

Start date

2010-07-09

Completion date

Unknown

Last updated

2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic male infertility MedDRA version: 9.1 Level: HLGT Classification code 10014701 MedDRA version: 9.1 Level: LLT Classification code 10021011

Interventions

Trade Name: GONAL F*SC 1PEN 900UI/1,5ML+14 Pharmaceutical Form: Solution for injection INN or Proposed INN: Follitropin alfa Concentration unit: IU international unit(s) Concentration type: equal Conc

Eligibility

Sex/Gender

Male

Inclusion criteria

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 (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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%	—

Measure

Time frame

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%

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Countries

Germany, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026