Diet and Its Relationship With Couple Infertility (ALIFERT)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Infertility

Study type: Observational

Funder types: Other

Identifiers

NCT01093378

P071224

Details and patient eligibility

About

This case-control multicentric study involving fertile and infertile couples aims at evaluating the impact on conception rate of nutritional parameters (biologic, clinic, anthropometric, and food questionnaire).

Full description

Infertility affects about 15% of couples. Many factors relating to lifestyle and environment are likely to influence fertility. As an adapted nutrition could prevent 30% of cancers, diet could be essential, but largely neglected, in the prevention of infertility.

Some studies tried to explore the impact of diet on male or female fertility, but very few focused on both. The aim of our study is to assess the role of nutrition in both fertile and infertile couples, taking into account most of factors relating to lifestyle. Clinical, anthropometric (BMI, fat mass), biological markers (non specific - glycaemia, lipids, inflammation, electrolytes - and specific - vitamins E, A, C, D, B, including folates and MTHFR polymorphism) and semen analysis, will be combined with validated questionnaires (nutrition, drugs, alcohol, tobacco, physical activity, sleep and stress).

The statistical analysis of correlations between nutritional and clinical data will provide information concerning the impact of nutrition on fertility.

Enrollment: 400 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Common to both infertile and fertile couples:

• Couples where both members are over eighteen and at childbearing age (≤38 for women and ≤ 45 for men)
• Couples where both members agreed to take part in the study
• Couples where both members completed a medical check-up and gave an informed consent. Infertile couples could be included following a medical consultation for infertility
• Couples with none of its member facing any comprehension difficulty in oral or written French language
• Couples where both members are affiliated to the French NHS [national health service] (beneficiary or legal claimant)

Specific to fertile couples:

• fertile couples who naturally and spontaneously conceived a or many children with a time to conceive shorter than 12 months.

Specific to infertile couples:

• Infertile couples (primary, infertility, inability to conceive a child after 12 months of unprotected sexual intercourse)
• Couples where the male partner has sperm parameters compatible with a natural conception
• Couples where the female partner does not present anovulation, ovarian insufficiency and or any uterus-tubal pathology

Exclusion criteria

Common to both infertile and fertile couples:

• couples where one of the members is under eighteen or not a childbearing age (>38 for women an >45 for men)
• couples where at least one member refused to give written agreement for the study
• couples where at least one member shows any known cardiovascular risk (diabetes, hypercholesterolemia, HBR)
• couples where at least one member shows any known cardiovascular pathology, digestive pathology, no good absorptive pathology or a cancer
• couples where at least one member faces some difficulty in understanding French language
• couples where at least one member is not affiliated with the French NHS (beneficiary or legal claimant)

Specific to fertile couples:

•Couples where the woman had a miscarriage or medical termination of pregnancy with current partner

Specific to infertile couples:

• Couples in which it is not the first pregnancy

• Couples with the male member showing either:

  • severe oligozoospermia (<5 millions/ml) or a confirmed azoospermia (absence of spermatozoid in the ejaculate)

  • a moderate non idiopathic oligozoospermia (5-20 millions/ml), related to one more of the following factors:

    1. toxic (chemotherapy, radiotherapy, drugs with a demonstrated effect on spermatogenesis)
    2. infectious
    3. anatomic: vasectomy, congenital anomaly (agenesis of vas deferens), long post-traumatic ischemia
    4. endocrine: hypogonadotropic, hypogonadism
    5. cytogenetic: klinefelter syndrome, translocation

• couples whose male partner shows an abnormality of the male genital tractus : VARICOCEME undescended,testis, testicular volume < 12ml

• couples whose female partner presents an anovulation, ovarian insufficiency or a proven uterus-tubal pathology

Trial design

400 participants in 2 patient groups

Fertile group

Description:

fertile group

Infertility group

Description:

Fertility troubles