Food Intake Among Women and Men in Fertility Treatment

Infertility Clinical Trial

— Food&Fertility  

Official title:

Food & Fertility - Does Food Intake Affect Your Fertility?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454046
• Other study ID #: AGR-2019-731-9666
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: August 1, 2026

Study information

• Verified date: January 2024
• Source: Aalborg University Hospital
• Contact: Ulrik S. Kesmodel, Professor
• Phone: (+45) 30206850
• Email: u.kesmodel[@]rn.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Food intake among women and men in fertility treatment
Filling in an FFQ

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Herlev Hospital Copenhagen	Herlev
Denmark	Regional Hospital Horsens	Horsens
Denmark	Odense University Hospital	Odense
Denmark	Regional Hospital Skive	Skive

Sponsors (6)

Lead Sponsor	Collaborator
Aalborg University Hospital	Herlev and Gentofte Hospital, Odense University Hospital, Regional Hospital Horsens, Regional Hospital Skive, Statens Serum Institut

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probability of live birth		From filling out the FFQ to birth (approximately 9-10months)
Primary	Probability of pregnancy		From filling out the FFQ to end of treatment cycle (approximately 3 weeks)
Primary	Semen quality		+/- 3 months from filling out the FFQ