Physical Activity and Fertility Care Study

NCT04002414 | Completed

• 1 other identifier: 19-28431
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Keywords

Physical Activity; In Vitro Fertilization; Ovarian Stimulation; Exercise

Outcome Measures

Primary Outcomes (3)

• Stress During Treatment based on daily end of day stress item

  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.

  14 days

• Anxiety/Depression During Treatment based on Patient-Reported Outcomes Measurement Information System Short Form (PROMIS-SF) Depression 4a and Anxiety 4a

  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.

  14 days

• Change in Stress during treatment based upon Perceived Stress Scale (PSS)-14

  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.

  4 weeks

Secondary Outcomes (8)

• Number of mature oocytes retrieved

  4 weeks

• Fertilization Rate

  4 weeks

• Blastulation Rate

  4 weeks

• Clinical Pregnancy Rate

  6 weeks

• Cancellation Rate

  2 weeks

Study Arms (4)

Usually Active- Decrease

ACTIVE COMPARATOR

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

Behavioral: Insufficient physical activity

Usually Active- Maintenance

EXPERIMENTAL

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

Behavioral: Sufficient physical activity

Usually Insufficiently Inactive- Increase

EXPERIMENTAL

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

Behavioral: Sufficient physical activity

Usually Insufficiently Inactive- Maintenance

ACTIVE COMPARATOR

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

Behavioral: Insufficient physical activity

Interventions

Sufficient physical activity BEHAVIORAL

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.

Usually Active- Maintenance; Usually Insufficiently Inactive- Increase

Insufficient physical activity BEHAVIORAL

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.

Usually Active- Decrease; Usually Insufficiently Inactive- Maintenance

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Infertility, Female; Motor Activity

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Behavior

Study Officials

• Heather Huddleston, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: May 15, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)