Impact of Folates in the Care of the Male Infertility

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Folic Acid; Vitamin B Complex

Criteria

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