Diet and Its Relationship With Couple Infertility

NCT01093378 | Completed

• 1 other identifier: P071224
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Infertility

Keywords

Infertility; Obesity; Dietary intake; Fertility; nutrition; diet; weight

Outcome Measures

Primary Outcomes (1)

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

  24 hours

Secondary Outcomes (7)

• Impact of genetic polymorphism on clinical and biological phenotypes linked to food behaviour in infertility context (MTHFR polymorphism for folates metabolism)

  12 months

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

  24 hours

• Impact of nutritional status on fertility and ART parameters

  24 hours

• Fertility : time to pregnancy (TTP)

  in the 6 months

• Male infertility : quantitative or qualitative semen abnormalities

  in the 6 months

Study Arms (2)

Fertile group

fertile group

Infertility group

Fertility troubles

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Paris 7 - Denis Diderot: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS

Bondy, 93143, France

Location

Related Publications (7)

• Dupont C, Hulot A, Jaffrezic F, Faure C, Czernichow S, di Clemente N, Racine C, Chavatte-Palmer P, Levy R; Alifert group. Female ponderal index at birth and idiopathic infertility. J Dev Orig Health Dis. 2020 Apr;11(2):154-158. doi: 10.1017/S2040174419000394. Epub 2019 Jul 16.

  PMID: 31309911 RESULT

• Caetano G, Rouen A, Dupont C, Levy R, Leger D, Sermondade N; ALIFERT Collaborative Group. Sleep and idiopathic infertility: a case-control study of 360 participants. Reprod Biomed Online. 2025 Nov;51(5):105040. doi: 10.1016/j.rbmo.2025.105040. Epub 2025 May 7.

  PMID: 40865394 DERIVED

• Bachelot G, Levy R, Bachelot A, Faure C, Czernichow S, Dupont C, Lamaziere A; Alifert Collaborative Group. Proof of concept and development of a couple-based machine learning model to stratify infertile patients with idiopathic infertility. Sci Rep. 2021 Dec 14;11(1):24003. doi: 10.1038/s41598-021-03165-3.

  PMID: 34907216 DERIVED

• Talla P, Faure C, Rigourd V, Czernichow S, Sermondade N, Levy R, Dupont C; ALIFERT collaborative group. Is There an Association of Being Breastfed as an Infant and Fertility Status as an Adult? Breastfeed Med. 2021 May;16(5):414-418. doi: 10.1089/bfm.2020.0130. Epub 2021 Mar 30.

  PMID: 33781087 DERIVED

• Dupont C, Faure C, Daoud F, Gautier B, Czernichow S, Levy R; ALIFERT collaborative group. Metabolic syndrome and smoking are independent risk factors of male idiopathic infertility. Basic Clin Androl. 2019 Jul 1;29:9. doi: 10.1186/s12610-019-0090-x. eCollection 2019.

  PMID: 31304019 DERIVED

• Faure C, Dupont C, Chavatte-Palmer P, Gautier B, Levy R; ALIFERT Collaborative Group. Are semen parameters related to birth weight? Fertil Steril. 2015 Jan;103(1):6-10. doi: 10.1016/j.fertnstert.2014.11.027.

  PMID: 25552408 DERIVED

• Faure C, Leveille P, Dupont C, Julia C, Chavatte-Palmer P; Alifert Group; Sutton A, Levy R. Are superoxide dismutase 2 and nitric oxide synthase polymorphisms associated with idiopathic infertility? Antioxid Redox Signal. 2014 Aug 1;21(4):565-9. doi: 10.1089/ars.2014.5831. Epub 2014 Feb 25.

  PMID: 24444339 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Impact of genetic polymorphism on clinical and biological phenotypes linked to food behaviour in infertility context

MeSH Terms

Conditions

Infertility; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Levy, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 25, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: June 1, 2015
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

FR (1)