Physical Activity and Fertility Care Study

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    600
  • sponsor
    University of California, San Francisco
Updated on 7 August 2021
ovarian stimulation
fertility preservation
in vitro fertilization

Summary

Randomized control trial to determine if performing the US Health and Human Services recommended amount of weekly physical activity during ovarian stimulation will differentially affect mental health or clinical outcomes of individuals who are usually active, insufficiently active, or inactive in their everyday lives. The goal overall is to assess for safety and value of physical activity during fertility treatment.

Description

Consenting participants will be separated into groups based on current average level of physical activity: Active women (complete >75 minutes of vigorous exercise or >150 minutes of moderate exercise per week) and Insufficiently active women (<75 minutes of vigorous exercise or <150 minutes of moderate exercise per week).

Between time of study enrollment and first ultrasound at start of ovarian stimulation cycle, the participants will be sent a link to questionnaires to assess general mental health parameters and physical fitness. They will be asked to complete the questionnaire prior to first ultrasound visit. At time of first ultrasound, participants who have completed the pre-stimulation survey will be randomized into one of two arms depending on their group: the active group will be randomized to (A) maintenance or (B) decreased activity arm, and the insufficiently active group will be randomized to (C) increased or (D) maintenance activity arm.

Also at first ultrasound, participants will be given a wearable heart rate monitor in order to track heart rate during the time from ovarian stimulation to first pregnancy test in order to monitor compliance to randomized activity level of each participant. The data from the monitors will be collected through a central university provided, password protected laptop utilizing an app platform. Furthermore, all participants will be asked to complete a daily mood, stress, discomfort questionnaire throughout stimulation. Participants will be expected to continue recommended physical activity level and questionnaires until day of egg retrieval. Wearable monitors will continue to be worn until time of first pregnancy test. Within the two weeks after completion of egg retrieval, participants will be sent a follow-up questionnaire to assess overall treatment stress and satisfaction with ovarian stimulation cycle. Those who completed in vitro fertilization and fresh embryo transfer will be sent a second follow-up questionnaire about 1-2 weeks after pregnancy test.

Details
Condition Female infertility
Treatment Sufficient physical activity, Insufficient physical activity
Clinical Study IdentifierNCT04002414
SponsorUniversity of California, San Francisco
Last Modified on7 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

First ovarian stimulation cycle for egg freezing or for in vitro fertilization
English speaking/reading
Patient at the Center for Reproductive Health, University of California San Francisco

Exclusion Criteria

Serious health conditions that limit amount of physical activity
BMI>40
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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