InfertilityFood&FertilityNCT05454046
Food Intake Among Women and Men in Fertility Treatment
An observational study of Infertility, run by Aalborg University Hospital at 8 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infertility
- What is being tested?
- Food intake among women and men in fertility treatment
- How many people
- 4,000 participants
- Where
- 8 sitesDenmark
- Study dates
- 1 Aug 2022to 1 Aug 2028
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Treatment with double donation (both semen and oocyte donation)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Denmark8 sites, 8 recruiting
- Recruiting
Aalborg University Hospital
Aalborg
Ulrik Kesmodel, u.kesmodel@rn.dk
- Recruiting
Klinik Bay, Gynaecology and Fertility
Aarhus
Bjørn Bay, bb@maigaard.dk
- Recruiting
Maigaard Fertility Clinic
Aarhus
Kirsten Simonsen, ks@maigaard.dk
- Recruiting
Copenhagen Fertility Center
Copenhagen
Frederikke Lindenberg, frederikke@lindenberg.dk
- Recruiting
Herlev Hospital Copenhagen
Herlev
Maria Borgstrøm, maria.borgstroem@regionh.dk
maria.borgstroem@regionh.dk
- Recruiting
Regional Hospital Horsens
Horsens
Peter Humaidan, peter.humaidan@midt.rm.dk
- Recruiting
Odense University Hospital
Odense, 5000
- Recruiting
Regional Hospital Skive
Skive
Kirstine Kirkegaard, kirstkrk@rm.dk
About this study
Official title: Food & Fertility - Does Food Intake Affect Your Fertility?
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Food intake among women and men in fertility treatment
- Keywords
- Fertility, Assisted reproductive techniques, Food, Diet, Dietary supplements, Semen quality, Live birth
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food intake among women and men in fertility treatmentOther
Filling in an FFQ
| Study group | Role | What they receive |
|---|---|---|
| Women | Not described Receives: Other: Food intake among women and men in fertility treatment | |
| Men | Not described Receives: Other: Food intake among women and men in fertility treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of live birth
Measured: From filling out the FFQ to birth (approximately 9-10months)
Probability of pregnancy
Measured: From filling out the FFQ to end of treatment cycle (approximately 3 weeks)
Semen quality
Measured: +/- 3 months from filling out the FFQ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital, Regional Hospital Skive, Regionshospitalet Horsens, Odense University Hospital, Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital.
- Responsible party
- Principal investigator, Ulrik Schiøler Kesmodel, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454046
- Sponsor's protocol ID
- AGR-2019-731-9666
- Acronym
- Food&Fertility
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37407049
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food & Fertility - Does Food Intake Affect Your Fertility?
- ClinicalTrials.gov ID
- NCT05454046
- Acronym / sponsor ID
- Food&Fertility / AGR-2019-731-9666
- Conditions
- Infertility
- Keywords
- Fertility, Assisted reproductive techniques, Food, Diet, Dietary supplements, Semen quality, Live birth
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital, Regional Hospital Skive, Regionshospitalet Horsens, Odense University Hospital, Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital.
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women | – | Other: Food intake among women and men in fertility treatment |
| Men | – | Other: Food intake among women and men in fertility treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Treatment with double donation (both semen and oocyte donation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food intake among women and men in fertility treatmentFilling in an FFQ | Other | Men, Women |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 37407049Buhl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Aalborg University Hospital at 8 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrik S. Kesmodel, Professor ((+45) 30206850, u.kesmodel@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of live birth (time frame: From filling out the FFQ to birth (approximately 9-10months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.