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NCT Number: NCT05454046

Food Intake Among Women and Men in Fertility Treatment

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

The Food & Fertility study is a multicenter prospective cohort study which is planned to enroll a total of 4000 women and men undergoing fertility treatment between 2022 and 2028. The data collection will take place at five Danish public and three private 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Food intake among women and men in fertility treatment

Other

Filling in an FFQ

Primary outcomes

  1. Probability of live birth

    Time frame: From filling out the FFQ to birth (approximately 9-10months)

  2. Probability of pregnancy

    Time frame: From filling out the FFQ to end of treatment cycle (approximately 3 weeks)

  3. Semen quality

    Time frame: +/- 3 months from filling out the FFQ

Study contacts

Contact information is provided by the study sponsor or research team.

Maria B. Borgstrøm

CONTACT

[email protected]

(+45) 29299493

Ulrik S. Kesmodel, Professor

CONTACT

[email protected]

(+45) 30206850

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital.
  • Herlev and Gentofte Hospital
  • Odense University Hospital
  • Regional Hospital Skive
  • Regionshospitalet Horsens

Registry information

Official study title

Food & Fertility - Does Food Intake Affect Your Fertility?

Acronym: Food&Fertility

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jul 12, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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