Actively Recruiting

Phase Not Applicable
Age: 18Years - 49Years
FEMALE
Healthy Volunteers
ID06705712

A Preconception Cohort Study of Physical Activity, Fertility, and Spontaneous Abortion Including a Randomized Controlled Trial

Led by University of Aarhus · Updated on 2025-01-28

530

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how physical activity affects fertility, pregnancy outcomes, and the risk of spontaneous abortion in women trying to conceive. It focuses on women without pregnancy complications and evaluates whether motivational counseling on physical activity can improve pregnancy chances and reduce complications such as gestational diabetes and preeclampsia. The study is part of a larger ongoing cohort investigating factors influencing fertility and pregnancy health. Participants are randomly assigned to one of two groups. Both groups receive a wrist-worn activity tracker to wear continuously during their attempt to conceive and, if pregnant, through the first trimester. The intervention group also receives motivational counseling, including educational materials, personalized goal setting on physical activity, and follow-up phone calls to encourage maintaining or increasing activity levels. The control group maintains their usual physical activity without additional support. Women in the study will wear activity trackers to monitor physical activity levels and complete questionnaires. Researchers will collect data on time to pregnancy, spontaneous abortion, and other pregnancy outcomes using self-reports and registry information. Physical activity is measured from randomization up to 15 months, time to pregnancy is tracked for up to 12 months, and spontaneous abortion is monitored up to 22 weeks of gestation. The study includes safety monitoring and aims to provide insights useful for women facing fertility challenges and pregnancy complications.

CONDITIONS

Brief Title

Physical Activity, Fertility, and Spontaneous Abortion in Danish Couples Trying to Conceive

Who Can Participate

Age: 18Years - 49Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Age between 18 and 49 years
  • In a relationship with a male partner
  • Currently trying to conceive
Not Eligible

You will not qualify if you...

  • Using any form of birth control
  • Receiving fertility treatment
  • Have been trying to conceive for more than six months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or online)

Outpatient Treatment

Duration - Up to 12 months or until pregnancy is reported

Participants wear a wrist-worn activity tracker 24/7 while trying to conceive and during the first trimester of pregnancy if conception occurs. Those in the intervention group receive motivational counseling calls to support physical activity goals.

2 phone calls for motivational counseling (intervention group)

Follow-up Monitoring

Duration - Up to 22 weeks from pregnancy confirmation

Participants who conceive are followed during pregnancy to monitor spontaneous abortion and other outcomes up to 22 weeks' gestation.

No specified visits; data collected via activity tracker and questionnaires

Trial Site Locations

Total: 1 location

1

Department of Clinical Epidemiology

Aarhus, Denmark, 8200

Actively Recruiting

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Research Team

S

Sissel Jessen Weissert, MD

M

Marie Dahl Jørgensen, MSPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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