Physical Activity and Fertility Care Study
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Sufficient physical activity; Insufficient physical activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be stratified into groups: "active" or "insufficiently active" 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
Keywords: Physical Activity; In Vitro Fertilization; Ovarian Stimulation; Exercise