Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
215 participants
INTERVENTIONAL
2020-05-15
2023-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Usually Active- Decrease
Participants who usually meet or exceed recommended levels of physical activity who will be asked to minimize activity during stimulation.
Insufficient physical activity
Physical activity less than the recommended levels by the US Health and Human Services Department: 75 minutes a week of vigorous activity or 150 minutes a week of moderate activity.
Usually Active- Maintenance
Participants who usually meet or exceed recommended levels of physical activity who will be asked to maintain usual level of activity during stimulation.
Sufficient physical activity
Physical activity at the recommended levels by the US Health and Human Services Department: 75 minutes a week of vigorous activity or 150 minutes a week of moderate activity.
Usually Insufficiently Inactive- Increase
Participants who are usually inactive who will be asked to try to increase activity to the recommended level during stimulation.
Sufficient physical activity
Physical activity at the recommended levels by the US Health and Human Services Department: 75 minutes a week of vigorous activity or 150 minutes a week of moderate activity.
Usually Insufficiently Inactive- Maintenance
Participants who are usually inactive who will be asked to maintain inactivity during stimulation.
Insufficient physical activity
Physical activity less than the recommended levels by the US Health and Human Services Department: 75 minutes a week of vigorous activity or 150 minutes a week of moderate activity.
Interventions
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Sufficient physical activity
Physical activity at the recommended levels by the US Health and Human Services Department: 75 minutes a week of vigorous activity or 150 minutes a week of moderate activity.
Insufficient physical activity
Physical activity less than the recommended levels by the US Health and Human Services Department: 75 minutes a week of vigorous activity or 150 minutes a week of moderate activity.
Eligibility Criteria
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Inclusion Criteria
* English speaking/reading
* Patient at the Center for Reproductive Health, University of California San Francisco
Exclusion Criteria
* BMI\>40
18 Years
43 Years
FEMALE
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Heather Huddleston, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Medical Center at Mission Bay
San Francisco, California, United States
Countries
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Other Identifiers
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19-28431
Identifier Type: -
Identifier Source: org_study_id