Effects of Physical Activity and Fitness, Cardiovascular- and Psychosocial Health on Medically Assisted Reproduction
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Clinical pregnancy rate (CPR) after medically assisted reproduction
Overview
Brief Summary
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 43 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Changes during hormonal stimulation: Physical activity behaviour(preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester)
- Changes during hormonal stimulation: Perceived stress(preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester)
- Changes during hormonal stimulation: Depressive symptoms(preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester)
- Ovulation trigger medication(During the 4 year observational period)
- Changes during hormonal stimulation: Anxiety symptoms(preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester)
- Changes during hormonal stimulation: Body image(preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester)
- Changes during hormonal stimulation: Sleep quality(preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester)
- Changes during hormonal stimulation: Quality of life(preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester)
- Changes during hormonal stimulation: Cognitive function(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)
- Changes during hormonal stimulation: Nutrition(preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester)
- 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)