AzTrials
AzTrials

InfertilityALIFERTNCT01093378

Diet and Its Relationship With Couple Infertility

An observational study of Infertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Infertility
How many people
400 participants
Where
1 siteFrance
Study dates
Oct 2009to Jun 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS

    Bondy, 93143

Other trials in France

About this study

Official title: 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).

Read the 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.

Conditions
Infertility
Keywords
Infertility, Obesity, Dietary intake, Fertility, nutrition, diet, weight
Medical subject headings
Infertility, Obesity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01093378
Study groupRoleWhat they receive
Fertile groupfertile group
Infertility groupFertility troubles

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 hours

Secondary outcomes (7)

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

    Measured: 12 months

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

    Measured: 24 hours

  3. Impact of nutritional status on fertility and ART parameters

    Measured: 24 hours

  4. Fertility : time to pregnancy (TTP)

    Measured: in the 6 months

  5. Male infertility : quantitative or qualitative semen abnormalities

    Measured: in the 6 months

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

    Measured: in the 6 months

  7. ART parameters, if appropriate

    Measured: in the 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionOct 2013
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01093378
Sponsor's protocol ID
P071224
Acronym
ALIFERT
Status last verified
Feb 2026
First submitted
26 Feb 2010
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31309911

  • 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.

    PubMed 40865394

  • 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.

    PubMed 34907216

  • 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.

    PubMed 33781087

  • 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.

    PubMed 31304019

  • 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.

    PubMed 25552408

  • 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.

    PubMed 24444339

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the nutritional status of fertile and infertile couples (food questionnaire - biologic, anthropometric and clinical balance). (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01093378, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 5 Nov 2026.

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