CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 162 enrolled
Drug / intervention
Folic acid +1 moredrug
Likely dose
Folic acid 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01407432
NCT01407432Phase 3Completed
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Impact of Folates in the Care of the Male Infertility

Assistance Publique - Hôpitaux de Paris·interventional·Posted Aug 2, 2011·Updated Jun 9, 2016

In Brief

A Phase 3 clinical trial evaluating Folic acid and placebo of folic acid for Male Infertility. Completed, enrolled 162 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Infertility
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2, 2011
Enrollment StartNov 1, 2011
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.9 years ago

Interventions

Folic aciddrug

Taking of folic acid 15 mg per day by hanging oral route during 3 at 4 months

placebo of folic aciddrug

Taking of placebo of folic acid by hanging oral route during 3 at 4 months