Evaluation of the FSH therapy efficacy in infertile men of unknown reason depending on two different FSH receptor types.
- Conditions
- Ideopathic infertility in menMedDRA version: 14.1Level: LLTClassification code 10025511Term: Male infertility, unspecifiedSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2010-020240-35-DE
- Lead Sponsor
- niversity of Modena and Reggio Emilia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 100
- age 20-50 years
- idiopathic male factor infertility for at least one year;
- homozygous FSHR allele at codon 680 (wild type: Asn/Asn or Ser/Ser);
- sperm DNA fragmentation index (DFI) > 15%;
- normal serum FSH levels (< 8 IU/L)
- normal serum LH, testosterone, prolactin and estradiol levels
- normal ovulatory 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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- azoospermia
- all known aetiologies of male infertility (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)
- all known aetiologies of female infertility in the partner (tubal blockage, endocrine abnormalities including anovulation and PCO, anatomical abnormalities, infections)
- heterozygous FSHR allele at codon 680
- drug abuse and major systemic diseases
- testicular insufficiency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate if success of FSH therapy in men with idiopathic infertility depends on a specific FSH receptor type (wild type) and if therapy in patients with a specific SNP in FSH receptor is signifcantly more ineffective. This would allow a more targeted therapy for this indication.;Secondary Objective: Improvement of pregnancy rates in sexual partner;Primary end point(s): DNA fragmentation index (DFI);Timepoint(s) of evaluation of this end point: Screening<br>Baseline (start ofr treatment)<br>After 12 weeks (end of treatment)<br>After 24 weeks (end of follow up)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): pregnancy in sexual partner, semen parameters, serum levels of inhibin B and AMH;Timepoint(s) of evaluation of this end point: pregnancy - any time<br>semen parameters - screening, 0 weeks, 12 weeks, 24 weeks<br>serum levesl of inhibin B and AMH - 0 weeks, 12 weeks, 24 weeks