Effects of Physical Activity and Fitness, Cardiovascular- and Psychosocial Health on Medically Assisted Reproduction
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: Health, fitness and lifestyle assessment.
- Who it may be relevant to
- Registry conditions: Infertility, Female. Basic parameters: 18 years — 43 years · Female.
- 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
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Health, fitness and lifestyle assessment
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.
Primary outcome measures
- Clinical pregnancy rate (CPR) after medically assisted reproduction [Time frame: During the 4 year observational period]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- University Hospital Basel — Basel
Identifiers
NCT: NCT07321665 · bb25Geiger;2025-00893