Clinical trial NCT05454046: Food Intake Among Women and Men in Fertility Treatment
Official title: Food & Fertility - Does Food Intake Affect Your Fertility?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Keywords: Fertility
Assisted reproductive techniques
Food
Diet
Dietary supplements
Semen quality
Live birth
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Statens Serum Institut
name: Herlev and Gentofte Hospital
name: Regional Hospital Skive
name: Regionshospitalet Horsens
name: Odense University Hospital
First posted: 2022-07-12
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women and men undergoing ART treatment or intrauterine insemination (IUI) at the fertility clinics at Aalborg University Hospital, Herlev University Hospital, and at the Regional Hospitals in Horsens and Skive will be invited to participate in the study (n=4000).

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.

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.

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)

Primary outcomes:
measure: Probability of live birth
timeFrame: From filling out the FFQ to birth (approximately 9-10months)
measure: Probability of pregnancy
timeFrame: From filling out the FFQ to end of treatment cycle (approximately 3 weeks)
measure: Semen quality
timeFrame: +/- 3 months from filling out the FFQ
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital Copenhagen
city: Horsens
country: Denmark
facility: Regional Hospital Horsens
city: Odense
country: Denmark
facility: Odense University Hospital
city: Skive
country: Denmark
facility: Regional Hospital Skive
Study officials:
References: