Diet and Its Relationship With Couple Infertility

Infertility Clinical Trial

— ALIFERT  

Official title:

Impact of the Diet Fertility : A Case-control Multicentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093378
• Other study ID #: P071224
• Status: Completed
• Phase: N/A
• First received: February 26, 2010
• Last updated: August 28, 2015
• Start date: October 2009
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
France	Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS	Bondy

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France, University Paris 7 - Denis Diderot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the nutritional status of fertile and infertile couples (food questionnaire - biologic, anthropometric and clinical balance).		24 hours	No
Secondary	Impact of genetic polymorphism on clinical and biological phenotypes linked to food behaviour in infertility context (MTHFR polymorphism for folates metabolism)		12 months	No
Secondary	Impact of lifestyle (alcohol and tabacco consumption, physical activity, anxiety and sleep) on diet and fertility		24 hours	No
Secondary	Impact of nutritional status on fertility and ART parameters		24 hours	No
Secondary	Fertility : time to pregnancy (TTP)		in the 6 months	No
Secondary	Male infertility : quantitative or qualitative semen abnormalities		in the 6 months	No
Secondary	Pregnancy and obstetrical pathologies, prematurity, twin birth, weight of the new-born in infertile couples		in the 6 months	No
Secondary	ART parameters, if appropriate		in the 6 months	No