NCT05454046

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Aug 2022Aug 2028

First Submitted

Initial submission to the registry

July 8, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

6 years

First QC Date

July 8, 2022

Last Update Submit

July 7, 2026

Conditions

Infertility

Keywords

FertilityAssisted reproductive techniquesFoodDietDietary supplementsSemen qualityLive birth

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Women

Other: Food intake among women and men in fertility treatment

Men

Other: Food intake among women and men in fertility treatment

Interventions

Food intake among women and men in fertility treatmentOTHER

Filling in an FFQ

MenWomen

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women and men undergoing ART treatment or intrauterine insemination (IUI) at the fertility clinics at Aalborg University Hospital, Herlev University Hospital, Odense University Hospital, the Regional Hospitals in Horsens and Skive Copenhagen Fertility Center, Klinik Bay, Gynaecology and Fertility, and Maigaard Fertility Clinic in Aarhus will be invited to participate in the study (n=4000).

You may qualify if:

  • 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.

You may not qualify if:

  • Treatment with double donation (both semen and oocyte donation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Klinik Bay, Gynaecology and Fertility

Aarhus, Denmark

RECRUITING

Maigaard Fertility Clinic

Aarhus, Denmark

RECRUITING

Copenhagen Fertility Center

Copenhagen, Denmark

RECRUITING

Herlev Hospital Copenhagen

Herlev, Denmark

RECRUITING

Regional Hospital Horsens

Horsens, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Regional Hospital Skive

Skive, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37407049DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Menogaril

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

NogalamycinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Central Study Contacts

Ulrik S. Kesmodel, Professor

CONTACT

(+45) 30206850u.kesmodel@rn.dk

Maria B. Borgstrøm

CONTACT

(+45) 29299493maria.borgstroem@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 12, 2022

Study Start

August 1, 2022

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(8)