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Идёт набор NCT07321665

Effects of Physical Activity and Fitness, Cardiovascular- and Psychosocial Health on Medically Assisted Reproduction

Наблюдательное Infertility, Female

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Health, fitness and lifestyle assessment.
Кому может быть актуально
Состояния в реестре: Infertility, Female. Базовые параметры: 18 лет — 43 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Clinical pregnancy rate (CPR) after medically assisted reproduction [Срок оценки: During the 4 year observational period]
Вторичные конечные точки (12)
  • Changes during hormonal stimulation: Physical activity behaviour [Срок оценки: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester]
  • Changes during hormonal stimulation: Perceived stress [Срок оценки: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester]
  • Changes during hormonal stimulation: Depressive symptoms [Срок оценки: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester]
  • Changes during hormonal stimulation: Anxiety symptoms [Срок оценки: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester]
  • Changes during hormonal stimulation: Body image [Срок оценки: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester]
  • Changes during hormonal stimulation: Sleep quality [Срок оценки: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester]
  • Changes during hormonal stimulation: Quality of life [Срок оценки: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester]
  • Changes during hormonal stimulation: Cognitive function [Срок оценки: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester]
  • Changes during hormonal stimulation: Nutrition [Срок оценки: preovulatory phase (day 5-14), during hormonal stimulation day (day 31-47), end of first trimester]
  • Amount and type of gonadotropins used [Срок оценки: During the 4 year observational period]
  • Ovulation trigger medication [Срок оценки: During the 4 year observational period]
  • Amount of eggs collected per ovarian pick-up (OPU) [Срок оценки: During the 4 year observational period]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • University Hospital Basel — Basel

Идентификаторы

NCT: NCT07321665 · bb25Geiger;2025-00893

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗