Food Intake Among Women and Men in Fertility Treatment

Recruiting

• Conditions: Infertility

• Registration Number: NCT05454046
• Lead Sponsor: Aalborg University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-12
• Study Start: 2022-08-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (5)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Herlev Hospital Copenhagen; 🇩🇰 Herlev, Denmark

Regional Hospital Horsens; 🇩🇰 Horsens, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Regional Hospital Skive; 🇩🇰 Skive, Denmark