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Completed

NCT Number: NCT04002414

Physical Activity and Fertility Care Study

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.

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Key information

Conditions

Infertility, Female Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Motor Activity Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Stress During Treatment based on daily end of day stress item

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Number of mature oocytes retrieved

    Time frame: 4 weeks

    Number of mature oocytes collected during oocyte retrieval after ovarian stimulation

  2. Fertilization Rate

    Time frame: 4 weeks

    Number of fertilized oocytes out of the total number that were mature

  3. Blastulation Rate

    Time frame: 4 weeks

    Number of blastocysts that developed out of the total number of day three embryo

  4. Clinical Pregnancy Rate

    Time frame: 6 weeks

    Number of ultrasound confirmed intrauterine pregnancies out of the total ovarian stimulation cycles for in vitro fertilization

  5. Cancellation Rate

    Time frame: 2 weeks

    The number of ovarian stimulation cycles that were cancelled out of all the ovarian stimulation cycles started

  6. Ovarian Torsion

    Time frame: 6 weeks

    Number of ovarian torsion cases that occurred out of the total ovarian stimulation cycles

  7. Live Birth Rate

    Time frame: 10 months

    Number of Live Birth out of the total ovarian stimulation cycles for in vitro fertilization

  8. Treatment continuation rate

    Time frame: 4 months

    Number of women who continue treatment after first cycle if not pregnant after the first cycle

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: PACE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2019
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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