Food&Fertility: Food Intake Among Women and Men in Fertility Treatment

Sponsor

Aalborg University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05454046

Collaborator

Statens Serum Institut (Other), Herlev and Gentofte Hospital (Other), Skive Regional Hospital (Other), Horsens Regional Hospital (Other)

4,000

Enrollment

Locations

Anticipated Duration (Months)

1000

Patients Per Site

27.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Food intake among women and men in fertility 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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

4000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Food & Fertility - Does Food Intake Affect Your Fertility?

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Probability of live birth [From filling out the FFQ to birth (approximately 9-10months)]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country
1	Aalborg University Hospital	Aalborg	Denmark
2	Herlev Hospital Copenhagen	Herlev	Denmark
3	Regional Hospital Horsens	Horsens	Denmark
4	Regional Hospital Skive	Skive	Denmark