NCT07321665

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
44mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jan 2026Jan 2030

First Submitted

Initial submission to the registry

December 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

January 16, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

December 22, 2025

Last Update Submit

January 16, 2026

Conditions

Infertility, Female

Keywords

Medically Assisted ReproductionAssisted Reproductive Technology (ART)In Vitro FertilizationCardiorespiratory FitnessCardiovascular HealthPhysical ActivityPerceived StressMental HealthPregnancy Rate

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (26)

  • 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

  • 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

  • +21 more secondary outcomes

Interventions

Health, fitness and lifestyle assessmentOTHER

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.

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Infertility, FemaleMotor ActivityPsychological Well-Being

Interventions

Health

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • James Geiger

    University Hospital of Basel

    STUDY CHAIR

Central Study Contacts

James Geiger, MD

CONTACT

0041 61 328 79 57james.geiger@usb.ch

Christoph Hauser, Dr.

CONTACT

0041 61 207 47 47christoph.hauser@unibas.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 7, 2026

Study Start

January 16, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

CH(1)