Clinical Trial: Impact of Folates in the Care of the Male Infertility

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Impact of Folates in the Care of the Male Infertility

Brief Summary: Unexplained male infertility is increasing, and, nowadays, the investigators only can propose palliative treatment, as In VITRO Fertilization (IVF). The folate metabolism is a key for the maintenance of genome integrity. A dysfunction in this pathway can be responsible of spermatogenesis defects, and further, of infertility. Few assays have shown that folate treatment can improve sperm parameters and fertility, till 30% in some of theses studies. The purpose of the investigators study is to demonstrate the impact of folates treatment on improvement of sperm parameters and on the rate of success of in VITRO fertilization procedures.

Detailed Summary: The folate impact in the treatment of male infertility will be reviewed by this large multicentric randomized controlled double-blind study comparing 2 parallel groups of 184 patients. In each group: folic acid 15mg/day versus placebo, orally for at least 3 months (duration of a cycle of spermatogenesis). This assay will evaluate the effectiveness of treatment with folic acid compared to its placebo in infertile men with the outcome of IVF+/-ICSI techniques (pregnancy rate). It will also assess the impact of folate therapy on sperm parameters, and further, the impact on abnormal sperm DNA methylation profiles.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: The rates of pregnancy in IVF +/- ICSI and spontaneous pregnancy according to the arm of treatment [ Time Frame: 3 months ]

Estimate the efficiency of the treatment by folic acid at infertile men on the improvement of improvement of the pregnancy rates in IVF +/- ICSI and spontaneous pregnancy before IVF +/- ICSI


Original Primary Outcome: The rates of pregnancy in IVF according to the arm of treatment [ Time Frame: 3 months ]

Estimate the efficiency of the treatment by folic acid at infertile men on the improvement of improvement of the pregnancy rates in IVF


Current Secondary Outcome:

  • The rate of improvement of the sperm parameters with acid folic treatment [ Time Frame: 3 months ]
    Estimate the efficiency of the treatment by folic acid on the sperm parameters
  • The rate of improvement of the nuclear quality of gametes with acid folic treatment [ Time Frame: 3 months ]
    Estimate the efficiency of the treatment by folic acid on the nuclear quality of gametes
  • The rate of pregnancy of couple with infertile men treated by folic acid according to the methylene-tetrahydrofolate reductase (MTHFR) genotype [ Time Frame: 3 months ]
    Estimate the impact of the methylene-tetrahydrofolate reductase (MTHFR) genotype of the patients on the rates of pregnancy according to the arm of treatment
  • The difference between the methylene-tetrahydrofolate reductase (MTHFR) genotype of the patients on sperm parameters according to the arm of treatment [ Time Frame: 3 months ]
    Estimate the impact of methylene-tetrahydrofolate reductase (MTHFR) genotype of the patients on sperm parameters according to the arm of treatment


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: June 28, 2011
Date Started: November 2011
Date Completion:
Last Updated: June 8, 2016
Last Verified: May 2016