Physical Activity and Fertility Care Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Infertility Female
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be stratified into groups: "active," "insufficiently active," or "inactive" based on current average physical activity. Randomization will be into one of two parallel arms, maintenance of current activity during ovarian stimulation, or modify activity level during ovarian stimulation.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 43 years
- Gender
- Only males
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), Insufficiently active women (<75 minutes of vigorous exercise or <150 minutes of moderate...
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), Insufficiently active women (<75 minutes of vigorous exercise or <150 minutes of moderate exercise per week), or Inactive women (no moderate or vigorous 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, and the inactive group will be randomized to (E) increased or (F) 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.
Tracking Information
- NCT #
- NCT04002414
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Heather Huddleston, MD University of California, San Francisco