Recruiting

SF/ActivityPhysical Activity's Impact on Fertility and Spontaneous Abortion

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What is being tested

Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive.

Behavioral
Who is being recruted

Abortion, Spontaneous+3

+ Urogenital Diseases

+ Behavior

From 18 to 49 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorUniversity of Aarhus
Study ContactSissel Jessen Weissert, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2025

Actual date on which the first participant was enrolled.

Infertility and spontaneous abortion are significant issues affecting many couples trying to become pregnant. This study looks into how physical activity might influence a woman's ability to conceive and maintain a healthy pregnancy. By understanding these connections, the study seeks to identify ways to improve fertility outcomes and reduce the risk of pregnancy loss. This investigation is particularly important because it could provide new insights into how lifestyle changes, like increased physical activity, might help those facing difficulties in conceiving naturally, without resorting to costly fertility treatments. Participants in this study are women who are trying to conceive and will be part of a randomized controlled trial. They will receive motivational counseling to encourage regular physical activity, which is monitored through both self-reports and objective measures. The study observes how this activity affects not just the chances of conception but also the risk of spontaneous abortion and other pregnancy-related outcomes like gestational diabetes and birth weight. By combining various data sources, the study aims to provide a comprehensive view of how physical activity impacts reproductive health, offering valuable information for healthcare professionals and couples facing infertility challenges.

Official TitleA Preconception Cohort Study of Physical Activity, Fertility, and Spontaneous Abortion - Including a Randomized Controlled Trial.
NCT06705712
Principal SponsorUniversity of Aarhus
Study ContactSissel Jessen Weissert, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

530 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 49 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Abortion, SpontaneousUrogenital DiseasesBehaviorFemale Urogenital Diseases and Pregnancy ComplicationsMotor ActivityPregnancy Complications

Criteria

4 inclusion criteria required to participate
Female

18-49 years

In a relationship with a male partner

Trying to conceive

3 exclusion criteria prevent from participating
Using birth control

Receiving fertility treatment

Have been trying to conceive for more than six months

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) including clear instructions on how to use it. They will be asked to wear the tracker 24/7 during the period they are trying to conceive plus the first trimester of their pregnancy. They will receive information material on the Danish national guidelines on PA, health benefits from PA, and suggestions on how to reduce sedentary behavior and increase daily activity. Based on the current PA level, they are asked to set personal goals to meet the PA recommendations and to split up sedentary behavior. They will receive a phone call two and five weeks after they received the activity tracker, to stimulate the participant's motivation to be physically active, to set goals for maintaining or increasing PA and to facilitate a revision of the goals if needed. The conversations will be inspired by motivational interviewing and the principles of this motivational technique.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Clinical Epidemiology

Aarhus, DenmarkOpen Department of Clinical Epidemiology in Google Maps
Recruiting
One Study Center