Diet and Its Relationship With Couple Infertility (ALIFERT)

August 28, 2015 updated by: Assistance Publique - Hôpitaux de Paris

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

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).

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy, France, 93143
        • Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Defined population after a screening in out-hospitalized patients in selected investigation sites

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Fertile group
fertile group
Infertility group
Fertility troubles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the nutritional status of fertile and infertile couples (food questionnaire - biologic, anthropometric and clinical balance).
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of genetic polymorphism on clinical and biological phenotypes linked to food behaviour in infertility context (MTHFR polymorphism for folates metabolism)
Time Frame: 12 months
12 months
Impact of lifestyle (alcohol and tabacco consumption, physical activity, anxiety and sleep) on diet and fertility
Time Frame: 24 hours
24 hours
Impact of nutritional status on fertility and ART parameters
Time Frame: 24 hours
24 hours
Fertility : time to pregnancy (TTP)
Time Frame: in the 6 months
in the 6 months
Male infertility : quantitative or qualitative semen abnormalities
Time Frame: in the 6 months
in the 6 months
Pregnancy and obstetrical pathologies, prematurity, twin birth, weight of the new-born in infertile couples
Time Frame: in the 6 months
in the 6 months
ART parameters, if appropriate
Time Frame: in the 6 months
in the 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
University Paris 7 - Denis Diderot

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

August 31, 2015

Last Update Submitted That Met QC Criteria

August 28, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P071224

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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