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Report for Clinical Trial NCT02349945

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Significance of the FSH Receptor Polymorphism p.N680S for the Efficacy of FSH Therapy of Idiopathic Male Infertility: a Pharmacogenetic Approach

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.

NCT02349945 Male Infertility
MeSH:Infertility Infertility, Male
HPO:Infertility Male infertility

1 Interventions

Name: follitropin alpha

Description: 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.
Type: Drug
Group Labels: 2

Arm 1 Arm 2


Primary Outcomes

Measure: Sperm DFI

Time: "after 12 weeks"

Secondary Outcomes

Measure: Sperm DFI (DNA Fragmentation Index)

Time: "Baseline"

Measure: Sperm DFI

Time: "after 24 weeks"

Other Outcomes

Measure: Pregnancy rate

Time: "baseline"

Measure: Pregnancy rate

Time: "After 12 weeks"

Measure: Pregnancy rate

Time: "after 24 weeks"

Measure: Sperm count

Time: "baseline"

Measure: Sperm count

Time: "after 12 weeks"

Measure: Sperm count

Time: "after 24 weeks

Description: Serum dosage

Measure: Inhibin B

Time: "baseline"

Description: Serum dosage

Measure: Inhibin B

Time: "after 12 weeks"

Description: Serum dosage

Measure: Inhibin B

Time: "after 24 weeks"

Description: Serum dosage of Anti-Mullerian Hormone

Measure: Anti-Mullerian Hormone (AMH)

Time: "baseline"

Description: Serum dosage of Anti-Mullerian Hormone

Measure: AMH

Time: "after 12 weeks"

Description: Serum dosage of Anti-Mullerian Hormone

Measure: AMH

Time: "after 24 weeks"

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs6166

FSH Receptor Polymorphism p.N680S and Efficacy of FSH Therapy 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).

In women, the response to FSH varies depending on the FSH receptor (FSHR) genotype, as determined by the non-synonymous SNP rs6166, which exchanges the amino acid Asn to Ser in codon 680.

The investigators hypothesize that the variable response to FSH in unselected infertile men is due to a different individual sensitivity to FSH as determined by the common FSHR polymorphism rs6166.



HPO Nodes


HPO: