Status:
COMPLETED
Impact of Folates in the Care of the Male Infertility
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Male Infertility
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 ...
Detailed 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: ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT01407432
Start Date
November 1 2011
End Date
April 1 2016
Last Update
June 9 2016
Active Locations (1)
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1
Service of gynaecology-obstetrics and medicine of the reproduction, Tenon Hospital - APHP
Paris, France, 75020