Clinical trial NCT04002414: Physical Activity and Fertility Care Study
Official title: Physical Activity and Fertility Care Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Keywords: Physical Activity
In Vitro Fertilization
Ovarian Stimulation
Exercise
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stress During Treatment based on daily end of day stress item
timeFrame: 14 days
measure: Anxiety/Depression During Treatment based on Patient-Reported Outcomes Measurement Information System Short Form (PROMIS-SF) Depression 4a and Anxiety 4a
timeFrame: 14 days
measure: Change in Stress during treatment based upon Perceived Stress Scale (PSS)-14
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of mature oocytes retrieved
timeFrame: 4 weeks
measure: Fertilization Rate
timeFrame: 4 weeks
measure: Blastulation Rate
timeFrame: 4 weeks
measure: Clinical Pregnancy Rate
timeFrame: 6 weeks
measure: Cancellation Rate
timeFrame: 2 weeks
measure: Ovarian Torsion
timeFrame: 6 weeks
measure: Live Birth Rate
timeFrame: 10 months
measure: Treatment continuation rate
timeFrame: 4 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay
state: California
Study officials:
affiliation: University of California, San Francisco
name: Heather Huddleston, MD
role: PRINCIPAL_INVESTIGATOR
References: