Physical Activity and Fertility Care Study (PACE)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Infertility, Female

Treatments: Behavioral: Insufficient physical activity; Behavioral: Sufficient physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT04002414

19-28431

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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215 participants in 4 patient groups

Usually Active- Decrease

Active Comparator group

Description:

Participants who usually meet or exceed recommended levels of physical activity who will be asked to minimize activity during stimulation.

Treatment:

Behavioral: Insufficient physical activity

Usually Active- Maintenance

Experimental group

Description:

Participants who usually meet or exceed recommended levels of physical activity who will be asked to maintain usual level of activity during stimulation.

Treatment:

Behavioral: Sufficient physical activity

Usually Insufficiently Inactive- Increase

Experimental group

Description:

Participants who are usually inactive who will be asked to try to increase activity to the recommended level during stimulation.

Treatment:

Behavioral: Sufficient physical activity

Usually Insufficiently Inactive- Maintenance

Active Comparator group

Description:

Participants who are usually inactive who will be asked to maintain inactivity during stimulation.

Treatment:

Behavioral: Insufficient physical activity