Infertility, FemaleREPRO-FITNCT07321665
Effects of Physical Activity and Fitness, Cardiovascular- and Psychosocial Health on Medically Assisted Reproduction
An observational study of Infertility, Female, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This prospective observational study aims to investigate the association between physical activity and clinical pregnancy rates in women undergoing medically assisted reproduction. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Health, fitness and lifestyle assessment
- How many people
- 115 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jan 2026to Jan 2030
- 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 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women experiencing infertility who are undergoing medically assisted reproduction (MAR) as part of routine clinical care.
Who may be able to join
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Age 18-43
- Planning to undergo MAR (eg, IUI, IVF, ICSI) - Physically able to cycle for cardiopulmonary exercise testing (CPET)
Who cannot join
- Any reduction in general state of health preventing from performing hormonal stimulation for MAR
- Absolute and relative contraindications for cardiopulmonary exercise testing (CPET) - No pregnancy at initial screening - Current illicit drug abuse including daily marijuana and CBD consumption (alcohol ≤2 drinks per day allowed)
- Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
- Severe renal impairment (e.g. estimated glomerular filtration rate <30 ml/min/m2)
- Known liver cirrhosis or other severe liver impairment
- Uncontrolled dysthyroidism
- Uncontrolled hypertension
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
James Geiger, MD, 0041 61 328 79 57, james.geiger@usb.ch
About this study
This prospective observational study aims to investigate the association between physical activity and clinical pregnancy rates in women undergoing medically assisted reproduction. Additionally, it evaluates how cardiorespiratory fitness, cardiovascular health, psychosocial factors, sleep quality, stress, and cognitive function relate to reproductive outcomes.
Read the detailed description
Infertility affects approximately 8-12% of couples of reproductive age worldwide and represents a major medical and psychosocial burden. Medically assisted reproduction (MAR), including in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), is widely used to address infertility, with more than 12,000 ART cycles performed annually in Switzerland. Despite advances in reproductive medicine, cumulative live birth rates following MAR remain moderate, highlighting the need to better understand modifiable factors that may influence treatment success.
Emerging evidence suggests that general health-related factors-such as physical activity, cardiorespiratory fitness, cardiovascular health, stress, psychosocial well-being, sleep quality, and cognitive function-may play an important role in fertility and MAR outcomes. While moderate physical activity has been associated with improved clinical pregnancy and live birth rates in some studies, the current literature is inconsistent, with conflicting findings regarding the optimal level of activity. Similarly, obesity and cardiovascular risk factors are known to negatively affect fertility and ART outcomes, potentially through mechanisms such as systemic inflammation, insulin resistance, and impaired ovarian responsiveness. Retinal microvascular markers have emerged as early indicators of cardiovascular risk and may provide additional insights into pregnancy-related complications.
Psychological stress, depression, poor sleep quality, and altered psychosocial health are prevalent among women experiencing infertility and may adversely affect reproductive physiology and treatment outcomes. Cognitive and psychosocial factors may further influence fertility indirectly through behavioral, hormonal, and lifestyle pathways. However, these domains are rarely assessed in an integrated and longitudinal manner in women undergoing MAR.
The primary objective of this exploratory, prospective, longitudinal observational study is to examine the association between physical activity and clinical pregnancy rate following MAR in biological women experiencing infertility. Secondary objectives include assessing the relationship of cardiorespiratory fitness, body mass index, blood pressure, retinal microvascular health, psychosocial health, perceived stress, sleep quality, and cognitive function with clinical pregnancy outcomes. Additional objectives are to evaluate short-term changes in physical activity, stress, psychosocial health, sleep, and cognition during hormonal stimulation, as well as changes in retinal microvascular health after completion of the first trimester in cases of pregnancy.
- Conditions
- Infertility, Female
- Being tested
- Health, fitness and lifestyle assessment
- Keywords
- Medically Assisted Reproduction, Assisted Reproductive Technology (ART), In Vitro Fertilization, Cardiorespiratory Fitness, Cardiovascular Health, Physical Activity, Perceived Stress, Mental Health, Pregnancy Rate
- Medical subject headings
- Infertility, Female, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health, fitness and lifestyle assessmentOther
Participants undergo a comprehensive, non-interventional longitudinal assessment of physical activity, cardiovascular health, psychosocial factors, sleep quality, and cognitive function integrated into routine medically assisted reproduction care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate (CPR) after medically assisted reproduction
Impact of Physical activity (PA) on clinical pregnancy rate (CPR) following medically assisted reproduction (MAR)
Measured: During the 4 year observational period
Secondary outcomes (26)
Changes during hormonal stimulation: Physical activity behaviour
Physical activity and inactivity over the past seven days will be assessed using the International Physical Activity Questionnaire (IPAQ).
Furthermore activity is measured by accelerometer before and during hormonal stimulation.
Measured: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Perceived stress
Psychological stress will be assessed using the Perceived Stress Scale.
The PSS uses a 5-point Likert scale (0-4) for each item, with scores calculated as follows:
Reverse Scoring: Positive items (e.g., PSS-10: items 4, 5, 7, 8) are reverse-scored (0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0).
Total Score: Sum all item scores after reversing positive items. PSS-10: Range 0-40
Interpretation: Higher scores indicate greater perceived stress. General guidelines (not diagnostic) include:
PSS-10: 0-13 (low), 14-26 (moderate), 27-40 (high)
Measured: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Depressive symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaires-9 (PHQ-9).
Scoring: Each question is scored 0 (not at all) to 3 (nearly every day), with a total score up to 27.
Severity Levels:
0-4: Minimal depression 5-9: Mild 10-14: Moderate 15-19: Moderately severe 20-27: Severe.
Measured: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Anxiety symptoms
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 questionnaire (GAD-7).
Each answer is 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day).
Total Score (0-21): Sum of all 7 items.
Severity Levels:
0-4: Minimal anxiety. 5-9: Mild anxiety. 10-14: Moderate anxiety. 15-21: Severe anxiety.
Measured: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Body image
Body image will be assessed using the Body Appreciation Scale-2 (BAS-2). Body Appreciation Scale-2 (BAS-2) is a 10-item measure of one's acceptance, favorable opinions and respect of their own body.
Response Options:
Never - 1 Seldom - 2 Sometimes - 3 Often - 5 Always - 5
Scoring Procedures The mean of the 10 items is calculated for the total score. Higher scores indicate higher body appreciation.
Measured: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Sleep quality
Sleep disturbances will be assessed using the Insomnia Severity Index (ISI). The Insomnia Severity Index (ISI) uses a 0-28 scale, with each of its seven items rated 0 (none) to 4 (very severe), where higher scores mean worse insomnia, categorizing results into no insomnia (0-7), subthreshold (8-14), moderate (15-21), and severe (22-28) insomnia, indicating clinical significance and potential need for treatment as scores rise
Measured: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Quality of life
Quality of life will be assessed using the WHO-5 Well-Being Index. The WHO-5 Well-Being Index scaling uses a 6-point Likert scale (0 to 5) for five questions about the past two weeks, summing them for a raw score (0-25), then multiplying by 4 to get a final score (0-100), where 0 is worst and 100 is best; scores below 50 suggest poor well-being and potential depression needing further checks, with a score of 28 or below often indicating depression
Measured: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Cognitive function
Cognitive function will be tested by strooper task.
Measured: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Nutrition
Dietary habits will be screened by mini-EAT (Eating Assessment Tool). Mini-Eating Assessment Tool (Mini-EAT) is a 9-item rapid dietary screener that includes fruits/vegetables, whole grains, refined grains, fish/seafood, legumes/nuts/seeds, low-fat dairy, high-fat dairy, and sweets consumption.
Measured: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Amount and type of gonadotropins used
Measured: During the 4 year observational period
Ovulation trigger medication
Measured: During the 4 year observational period
Amount of eggs collected per ovarian pick-up (OPU)
Measured: During the 4 year observational period
Complications (Ovarian hyperstimulation syndrome, ovarian torsion, bleeding or infection after OPU)
Measured: During the 4 year observational period
IVF fertilisation rate
Measured: During the 4 year observational period
ICSI fertilisation rate
Measured: During the 4 year observational period
Blastocyst development rate
Measured: During the 4 year observational period
Blastocyst grading
Measured: During the 4 year observational period
Evaluation of fresh vs. frozen embryo transfer
Measured: During the 4 year observational period
Implantation rate
Measured: During the 4 year observational period
Time to pregnancy
Measured: During the 4 year observational period
Miscarriage rate (before twelve weeks of pregnancy)
Measured: During the 4 year observational period
Pregnancy complications
Measured: During the 4 year observational period
Preterm birth
Measured: During the 4 year observational period
Cumulative life birth rate
Measured: During the 4 year observational period
Fetal malformations
Measured: During the 4 year observational period
Perinatal death
Measured: During the 4 year observational period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start16 Jan 2026
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Geiger, Study chair, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321665
- Sponsor's protocol ID
- bb25Geiger;2025-00893
- Acronym
- REPRO-FIT
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity and Fitness, Cardiovascular- and Psychosocial Health on Medically Assisted Reproduction
- ClinicalTrials.gov ID
- NCT07321665
- Acronym / sponsor ID
- REPRO-FIT / bb25Geiger;2025-00893
- Conditions
- Infertility, Female
- Keywords
- Medically Assisted Reproduction, Assisted Reproductive Technology (ART), In Vitro Fertilization, Cardiorespiratory Fitness, Cardiovascular Health, Physical Activity, Perceived Stress, Mental Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 7 Jan 2026 (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.
This prospective observational study aims to investigate the association between physical activity and clinical pregnancy rates in women undergoing medically assisted reproduction. Additionally, it evaluates how cardiorespiratory fitness, cardiovascular health, psychosocial factors, sleep quality, stress, and cognitive function relate to reproductive outcomes.
Detailed description
Infertility affects approximately 8-12% of couples of reproductive age worldwide and represents a major medical and psychosocial burden. Medically assisted reproduction (MAR), including in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), is widely used to address infertility, with more than 12,000 ART cycles performed annually in Switzerland. Despite advances in reproductive medicine, cumulative live birth rates following MAR remain moderate, highlighting the need to better understand modifiable factors that may influence treatment success.
Emerging evidence suggests that general health-related factors-such as physical activity, cardiorespiratory fitness, cardiovascular health, stress, psychosocial well-being, sleep quality, and cognitive function-may play an important role in fertility and MAR outcomes. While moderate physical activity has been associated with improved clinical pregnancy and live birth rates in some studies, the current literature is inconsistent, with conflicting findings regarding the optimal level of activity. Similarly, obesity and cardiovascular risk factors are known to negatively affect fertility and ART outcomes, potentially through mechanisms such as systemic inflammation, insulin resistance, and impaired ovarian responsiveness. Retinal microvascular markers have emerged as early indicators of cardiovascular risk and may provide additional insights into pregnancy-related complications.
Psychological stress, depression, poor sleep quality, and altered psychosocial health are prevalent among women experiencing infertility and may adversely affect reproductive physiology and treatment outcomes. Cognitive and psychosocial factors may further influence fertility indirectly through behavioral, hormonal, and lifestyle pathways. However, these domains are rarely assessed in an integrated and longitudinal manner in women undergoing MAR.
The primary objective of this exploratory, prospective, longitudinal observational study is to examine the association between physical activity and clinical pregnancy rate following MAR in biological women experiencing infertility. Secondary objectives include assessing the relationship of cardiorespiratory fitness, body mass index, blood pressure, retinal microvascular health, psychosocial health, perceived stress, sleep quality, and cognitive function with clinical pregnancy outcomes. Additional objectives are to evaluate short-term changes in physical activity, stress, psychosocial health, sleep, and cognition during hormonal stimulation, as well as changes in retinal microvascular health after completion of the first trimester in cases of pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women experiencing infertility who are undergoing medically assisted reproduction (MAR) as part of routine clinical care.
Key inclusion criteria (3 listed)
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Age 18-43
- Planning to undergo MAR (eg, IUI, IVF, ICSI) - Physically able to cycle for cardiopulmonary exercise testing (CPET)
Key exclusion criteria (8 listed)
- Any reduction in general state of health preventing from performing hormonal stimulation for MAR
- Absolute and relative contraindications for cardiopulmonary exercise testing (CPET) - No pregnancy at initial screening - Current illicit drug abuse including daily marijuana and CBD consumption (alcohol ≤2 drinks per day allowed)
- Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
- Severe renal impairment (e.g. estimated glomerular filtration rate <30 ml/min/m2)
- Known liver cirrhosis or other severe liver impairment
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 |
|---|---|---|
| Health, fitness and lifestyle assessmentParticipants undergo a comprehensive, non-interventional longitudinal assessment of physical activity, cardiovascular health, psychosocial factors, sleep quality, and cognitive function integrated into routine medically assisted reproduction care. | Other | – |
Primary outcome
Clinical pregnancy rate (CPR) after medically assisted reproduction
Time frame: During the 4 year observational period
Impact of Physical activity (PA) on clinical pregnancy rate (CPR) following medically assisted reproduction (MAR)
26 secondary outcomes
Changes during hormonal stimulation: Physical activity behaviour
Time frame: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Perceived stress
Time frame: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Depressive symptoms
Time frame: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Anxiety symptoms
Time frame: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Body image
Time frame: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Sleep quality
Time frame: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Quality of life
Time frame: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Cognitive function
Time frame: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Changes during hormonal stimulation: Nutrition
Time frame: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Amount and type of gonadotropins used
Time frame: During the 4 year observational period
Ovulation trigger medication
Time frame: During the 4 year observational period
Amount of eggs collected per ovarian pick-up (OPU)
Time frame: During the 4 year observational period
Complications (Ovarian hyperstimulation syndrome, ovarian torsion, bleeding or infection after OPU)
Time frame: During the 4 year observational period
IVF fertilisation rate
Time frame: During the 4 year observational period
ICSI fertilisation rate
Time frame: During the 4 year observational period
Blastocyst development rate
Time frame: During the 4 year observational period
Blastocyst grading
Time frame: During the 4 year observational period
Evaluation of fresh vs. frozen embryo transfer
Time frame: During the 4 year observational period
Implantation rate
Time frame: During the 4 year observational period
Time to pregnancy
Time frame: During the 4 year observational period
Miscarriage rate (before twelve weeks of pregnancy)
Time frame: During the 4 year observational period
Pregnancy complications
Time frame: During the 4 year observational period
Preterm birth
Time frame: During the 4 year observational period
Cumulative life birth rate
Time frame: During the 4 year observational period
Fetal malformations
Time frame: During the 4 year observational period
Perinatal death
Time frame: During the 4 year observational period
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 21 Jan 2026.
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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.
James Geiger study chair
University Hospital of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 8 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 James Geiger, MD (0041 61 328 79 57, james.geiger@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (CPR) after medically assisted reproduction (time frame: During the 4 year observational period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.