About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial population
Women experiencing infertility who are undergoing medically assisted reproduction (MAR) as part of routine clinical care.
Trial design
Cohort
Prospective
Treatments tested in this trial
Health, fitness and lifestyle assessment
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Clinical pregnancy rate (CPR) after medically assisted reproduction
Impact of Physical activity (PA) on clinical pregnancy rate (CPR) following medically assisted reproduction (MAR)
Secondary outcomes
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.
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)
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.
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.
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