Food Intake Among Women and Men in Fertility Treatment

NCT ID: NCT05454046

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-08-01

Brief Summary

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Worldwide infertility is highly prevalent and lifestyle factors, such as food intake, could have an essential role in the success of a fertility treatment. The literature is not consistent and adequate for recommendations to the increasing number of women and men of reproductive age who ask for lifestyle guidance. Therefore, the aims of the Food \& Fertility study will be to investigate the association between food intake and semen quality, pregnancy- and live birth rates in women and men undergoing assisted reproductive technology (ART) treatment.

Detailed Description

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The Food \& Fertility study is a multicenter prospective cohort study which is planned to enroll a total of 4000 women and men between 2022 and 2024. The data collection will take place in four fertility clinics through a web-based food frequency questionnaire (FFQ). Data on sperm quality and pregnancy- and live birth rates will be obtained from medical records and national registers.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women

Food intake among women and men in fertility treatment

Intervention Type OTHER

Filling in an FFQ

Men

Food intake among women and men in fertility treatment

Intervention Type OTHER

Filling in an FFQ

Interventions

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Food intake among women and men in fertility treatment

Filling in an FFQ

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women and men undergoing fertility treatment: in vitro fertilization (IVF), intracytoplasmatic sperm injection (ICSI), frozen-thawed embryo transfer (FET) or intrauterine insemination (IUI).
* Availability of a semen sample analyzed 3 months before or after filling in the FFQ.
* Read and understands Danish.

Exclusion Criteria

* Treatment with double donation (both semen and oocyte donation)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Statens Serum Institut

OTHER

Sponsor Role collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role collaborator

Regional Hospital Skive

UNKNOWN

Sponsor Role collaborator

Regionshospitalet Horsens

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Responsible Party

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Ulrik Schiøler Kesmodel

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status RECRUITING

Herlev Hospital Copenhagen

Herlev, , Denmark

Site Status RECRUITING

Regional Hospital Horsens

Horsens, , Denmark

Site Status RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status NOT_YET_RECRUITING

Regional Hospital Skive

Skive, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Ulrik S. Kesmodel, Professor

Role: CONTACT

(+45) 30206850

Maria B. Borgstrøm

Role: CONTACT

(+45) 29299493

References

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Buhl Borgstrom MB, Ahrendt Bjerregaard A, Olsen SF, Gabrielsen A, Humaidan P, Kesmodel US. Food & Fertility Study: study protocol for a Danish multicentre prospective cohort study investigating the association between food intake and semen quality, pregnancy and birth outcomes in infertile women and men. BMJ Open. 2023 Jul 4;13(7):e068354. doi: 10.1136/bmjopen-2022-068354.

Reference Type DERIVED
PMID: 37407049 (View on PubMed)

Other Identifiers

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AGR-2019-731-9666

Identifier Type: -

Identifier Source: org_study_id

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