A Phase 3 interventional study of Folic acid and placebo of folic acid in Male Infertility, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-06-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 162 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
tablets of 5 mg of folic acid
Drug: Folic acid
Tablets of placebo of folic acid
Drug: placebo of folic acid
Taking of folic acid 15 mg per day by hanging oral route during 3 at 4 months
Taking of placebo of folic acid by hanging oral route during 3 at 4 months
The rates of pregnancy in IVF +/- ICSI and spontaneous pregnancy according to the arm of treatment
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
Time frame: 3 months
The rate of improvement of the sperm parameters with acid folic treatment
Estimate the efficiency of the treatment by folic acid on the sperm parameters
Time frame: 3 months
The rate of improvement of the nuclear quality of gametes with acid folic treatment
Estimate the efficiency of the treatment by folic acid on the nuclear quality of gametes
Time frame: 3 months
The rate of pregnancy of couple with infertile men treated by folic acid according to the methylene-tetrahydrofolate reductase (MTHFR) genotype
Estimate the impact of the methylene-tetrahydrofolate reductase (MTHFR) genotype of the patients on the rates of pregnancy according to the arm of treatment
Time frame: 3 months
The difference between the methylene-tetrahydrofolate reductase (MTHFR) genotype of the patients on sperm parameters according to the arm of treatment
Estimate the impact of methylene-tetrahydrofolate reductase (MTHFR) genotype of the patients on sperm parameters according to the arm of treatment
Time frame: 3 months
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris