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Recruiting NCT05454046

Food Intake Among Women and Men in Fertility Treatment

Observational Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Food intake among women and men in fertility treatment.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Food & Fertility - Does Food Intake Affect Your Fertility?

Overview

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 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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 8 centers
  • Aalborg University Hospital — Aalborg
  • Klinik Bay, Gynaecology and Fertility — Aarhus
  • Maigaard Fertility Clinic — Aarhus
  • Copenhagen Fertility Center — Copenhagen
  • Herlev Hospital Copenhagen — Herlev
  • Regional Hospital Horsens — Horsens
  • Odense University Hospital — Odense
  • Regional Hospital Skive — Skive

Publications

  • 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 37407049

Identifiers

NCT: NCT05454046 · AGR-2019-731-9666

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗