Effects of Physical Activity and Fitness, Cardiovascular- and Psychosocial Health on Medically Assisted Reproduction (REPRO-FIT)

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female
• Intervention / Treatment: Other: Health, fitness and lifestyle assessment

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 Type: Observational
• Enrollment (Estimated): 115

Contacts and Locations

• Study Contact: Name: James Geiger, MD; Phone Number: 0041 61 328 79 57; Email: james.geiger@usb.ch
• Study Contact Backup: Name: Christoph Hauser, Dr.; Phone Number: 0041 61 207 47 47; Email: christoph.hauser@unibas.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: James Geiger, MD; Phone Number: 0041 61 328 79 57; Email: james.geiger@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Women experiencing infertility who are undergoing medically assisted reproduction (MAR) as part of routine clinical care.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate (CPR) after medically assisted reproduction	Impact of Physical activity (PA) on clinical pregnancy rate (CPR) following medically assisted reproduction (MAR)	During the 4 year observational period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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	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.	preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester
Amount and type of gonadotropins used		During the 4 year observational period
Ovulation trigger medication		During the 4 year observational period
Amount of eggs collected per ovarian pick-up (OPU)		During the 4 year observational period
Complications (Ovarian hyperstimulation syndrome, ovarian torsion, bleeding or infection after OPU)		During the 4 year observational period
IVF fertilisation rate		During the 4 year observational period
ICSI fertilisation rate		During the 4 year observational period
Blastocyst development rate		During the 4 year observational period
Blastocyst grading		During the 4 year observational period
Evaluation of fresh vs. frozen embryo transfer		During the 4 year observational period
Implantation rate		During the 4 year observational period
Time to pregnancy		During the 4 year observational period
Miscarriage rate (before twelve weeks of pregnancy)		During the 4 year observational period
Pregnancy complications		During the 4 year observational period
Preterm birth		During the 4 year observational period
Cumulative life birth rate		During the 4 year observational period
Fetal malformations		During the 4 year observational period
Perinatal death		During the 4 year observational period
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)	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.	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.	preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: James Geiger, University Hospital of Basel

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Mental Health; In Vitro Fertilization; Cardiovascular Health; Pregnancy Rate; Cardiorespiratory Fitness; Perceived Stress; Assisted Reproductive Technology (ART); Medically Assisted Reproduction
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Behavior; Personal Satisfaction; Infertility, Female; Psychological Well-Being; Motor Activity; Population Characteristics; Health
• Other Study ID Numbers: bb25Geiger;2025-00893

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No