Food Intake Among Women and Men in Fertility Treatment (Food&Fertility)

January 29, 2024 updated by: Ulrik Schiøler Kesmodel, Aalborg University Hospital

Food & Fertility - Does Food Intake Affect Your Fertility?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

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

Study Contact

  • Name: Ulrik S. Kesmodel, Professor
  • Phone Number: (+45) 30206850
  • Email: u.kesmodel@rn.dk

Study Contact Backup

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Recruiting
        • Aalborg University Hospital
      • Herlev, Denmark
        • Recruiting
        • Herlev Hospital Copenhagen
      • Horsens, Denmark
        • Recruiting
        • Regional Hospital Horsens
      • Odense, Denmark, 5000
        • Not yet recruiting
        • Odense University Hospital
      • Skive, Denmark
        • Recruiting
        • Regional Hospital Skive

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women and men undergoing ART treatment or intrauterine insemination (IUI) at the fertility clinics at Aalborg University Hospital, Herlev University Hospital, and at the Regional Hospitals in Horsens and Skive will be invited to participate in the study (n=4000).

Description

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)

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
Intervention / Treatment
Women
Other: Food intake among women and men in fertility treatment
Filling in an FFQ
Men
Other: Food intake among women and men in fertility treatment
Filling in an FFQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Probability of live birth
Time Frame: From filling out the FFQ to birth (approximately 9-10months)
From filling out the FFQ to birth (approximately 9-10months)
Probability of pregnancy
Time Frame: From filling out the FFQ to end of treatment cycle (approximately 3 weeks)
From filling out the FFQ to end of treatment cycle (approximately 3 weeks)
Semen quality
Time Frame: +/- 3 months from filling out the FFQ
+/- 3 months from filling out the FFQ

Collaborators and Investigators

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

Sponsor

Aalborg University Hospital

Collaborators

Odense University Hospital
Herlev and Gentofte Hospital
Statens Serum Institut
Regional Hospital Skive
Regional Hospital Horsens

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 (Actual)

August 1, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 8, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGR-2019-731-9666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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