Skip to main content
OpenTrials
Completed

NCT Number: NCT01093378

Diet and Its Relationship With Couple Infertility

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS

Bondy, 93143, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • toxic (chemotherapy, radiotherapy, drugs with a demonstrated effect on spermatogenesis)
  • infectious
  • anatomic: vasectomy, congenital anomaly (agenesis of vas deferens), long post-traumatic ischemia
  • endocrine: hypogonadotropic, hypogonadism
  • 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

Treatment and study plan

Primary outcomes

  1. Evaluate the nutritional status of fertile and infertile couples (food questionnaire - biologic, anthropometric and clinical balance).

    Time frame: 24 hours

Secondary outcomes

  1. 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

  2. Impact of lifestyle (alcohol and tabacco consumption, physical activity, anxiety and sleep) on diet and fertility

    Time frame: 24 hours

  3. Impact of nutritional status on fertility and ART parameters

    Time frame: 24 hours

  4. Fertility : time to pregnancy (TTP)

    Time frame: in the 6 months

  5. Male infertility : quantitative or qualitative semen abnormalities

    Time frame: in the 6 months

  6. Pregnancy and obstetrical pathologies, prematurity, twin birth, weight of the new-born in infertile couples

    Time frame: in the 6 months

  7. ART parameters, if appropriate

    Time frame: in the 6 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin
  • University Paris 7 - Denis Diderot

Registry information

Official study title

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

Acronym: ALIFERT

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Mar 25, 2010
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.