Impact of Folates in the Care of the Male Infertility (FOLFIV)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Male Infertility

Treatments: Drug: placebo of folic acid; Drug: Folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01407432

P 100108

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 162 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Couple whose man is from 18 to 60 years old
• Couple whose man presents an infertility indicating a care in VITRO fertilization with or without intracytoplasmic sperm injection (IVF +/- ICSI)
• Couple whose spouse is from 18 to 38 years old
• Couple whose spouse do not present particular factors of infertility
• Couple Taken care in IVF +/- ICSI
• Couple with social insurance
• 2 members of the couple having signed the consent

Exclusion criteria

• Etiology of not genetic known male infertility : infertility of neoplastic origine, infertility of definitive obstructive origin
• Presence of a factor of feminine infertility : A definitive infertility tubal, Turned out ovarian incapacity (FSH > 9 and/or CFA <= 8)
• Male infertility requiring the appeal to some sperm testicular or in some frozen sperm- Men or women attend of HIV or hepatitis B or C
• Epileptic men
• Men under anti-folic treatment
• Men presenting a big sensibility to the folic acid or to one of the constituents of the drug
• Couple of which one of the partners refuses to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 2 patient groups, including a placebo group

Folic acid

Experimental group

Description:

tablets of 5 mg of folic acid

Treatment:

Drug: Folic acid

Placebo

Placebo Comparator group

Description:

Tablets of placebo of folic acid

Treatment:

Drug: placebo of folic acid