Physical Activity and Fertility Care Study

Not Applicable

Completed

• Conditions: Infertility, Female
• Interventions: Behavioral: Sufficient physical activity; Behavioral: Insufficient physical activity

• Registration Number: NCT04002414
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-06-28
• Study Start: 2020-05-15
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 215

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

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Exclusion Criteria

• Serious health conditions that limit amount of physical activity
• BMI>40

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usually Insufficiently Inactive- Increase	Sufficient physical activity	Participants who are usually inactive who will be asked to try to increase activity to the recommended level during stimulation.
Usually Active- Decrease	Insufficient physical activity	Participants who usually meet or exceed recommended levels of physical activity who will be asked to minimize activity during stimulation.
Usually Insufficiently Inactive- Maintenance	Insufficient physical activity	Participants who are usually inactive who will be asked to maintain inactivity during stimulation.
Usually Active- Maintenance	Sufficient physical activity	Participants who usually meet or exceed recommended levels of physical activity who will be asked to maintain usual level of activity during stimulation.

Primary Outcome Measures

Name	Time	Method
Anxiety/Depression During Treatment based on Patient-Reported Outcomes Measurement Information System Short Form (PROMIS-SF) Depression 4a and Anxiety 4a	14 days	Measured with daily PROMIS-SF Depression 4a and Anxiety 4a questions for the approximately two weeks of ovarian stimulation. The PROMIS-SF Anxiety 4a item bank assesses self-reported fear, anxious misery, hyperarousal, and arousal-related somatic symptoms (e.g., dizziness). The PROMIS-SF Depression 4a item bank assesses self-reported negative mood (e.g., sadness), views of self (e.g., worthlessness), social cognition (e.g., loneliness), and decreased positive affect and engagement. Items are all answered on a 5-point scale from 1=Never to 5=Always. Scores can range from 0 meaning no anxiety/depression to 40 meaning high anxiety/depression.
Change in Stress during treatment based upon Perceived Stress Scale (PSS)-14	4 weeks	Change in mean PSS-14 score from pre-treatment to post-treatment. PSS-14 includes 14 items, 7 negatively states items and 7 positively stated items. Each item is rated on a 5-point scale (0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often). The positively stated items re reverse coded, so all items are summed to create a total score. Scores can range from 0 meaning no stress to 56 meaning severely stressed.
Stress During Treatment based on daily end of day stress item	14 days	As validated in prior studies (Schliep et al. 2015) examining stress and infertility, we will ask participants, "how did your stress levels today compare to your usual level of stress?" Participants will respond on a 3-point scale with the following options: 1 (not stressful), 2 (a little stressful), 3 (very stressful). We plan to compare average daily stress as well as stress trend over the 14-days of stimulation.

Secondary Outcome Measures

Name	Time	Method
Live Birth Rate	10 months	Number of Live Birth out of the total ovarian stimulation cycles for in vitro fertilization
Cancellation Rate	2 weeks	The number of ovarian stimulation cycles that were cancelled out of all the ovarian stimulation cycles started
Blastulation Rate	4 weeks	Number of blastocysts that developed out of the total number of day three embryo
Number of mature oocytes retrieved	4 weeks	Number of mature oocytes collected during oocyte retrieval after ovarian stimulation
Fertilization Rate	4 weeks	Number of fertilized oocytes out of the total number that were mature
Ovarian Torsion	6 weeks	Number of ovarian torsion cases that occurred out of the total ovarian stimulation cycles
Treatment continuation rate	4 months	Number of women who continue treatment after first cycle if not pregnant after the first cycle
Clinical Pregnancy Rate	6 weeks	Number of ultrasound confirmed intrauterine pregnancies out of the total ovarian stimulation cycles for in vitro fertilization

Trial Locations

Locations (1)

UCSF Medical Center at Mission Bay; 🇺🇸 San Francisco, California, United States