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Physical Activity and Fertility Care Study (PACE)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infertility, Female | Behavioral: Sufficient physical activity Behavioral: Insufficient physical activity | Not Applicable |
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), Insufficiently active women (<75 minutes of vigorous exercise or <150 minutes of moderate exercise per week), or Inactive women (no moderate or vigorous 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, and the inactive group will be randomized to (E) increased or (F) 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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Patients will be stratified into groups: "active," "insufficiently active," or "inactive" 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 |
| Official Title: | Physical Activity and Fertility Care Study |
| Actual Study Start Date : | May 15, 2020 |
| Estimated Primary Completion Date : | September 1, 2021 |
| Estimated Study Completion Date : | September 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Usually Active- Decrease
Participants who usually meet or exceed recommended levels of physical activity who will be asked to minimize activity during stimulation.
|
Behavioral: Insufficient physical 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.
|
|
Experimental: Usually Active- Maintenance
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
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.
|
|
Experimental: Usually Insufficiently Active- Increase
Participants who are usually insufficiently active (do not meet recommended levels of physical activity) who will be asked to increase activity to the recommended level during stimulation.
|
Behavioral: Sufficient physical activity
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.
|
|
Active Comparator: Usually Insufficiently Active- Maintenance
Participants who are usually insufficiently active (do not meet recommended levels of physical activity) who will be asked to maintain current level of activity.
|
Behavioral: Insufficient physical 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.
|
|
Experimental: Usually Inactive- Increase
Participants who are usually inactive who will be asked to try to increase activity to the recommended level during stimulation.
|
Behavioral: Sufficient physical activity
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.
|
|
Active Comparator: Usually Inactive- Maintenance
Participants who are usually inactive who will be asked to maintain inactivity during stimulation.
|
Behavioral: Insufficient physical 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.
|
- 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.
- 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.
- 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.
- Number of mature oocytes retrieved [ Time Frame: 4 weeks ]Number of mature oocytes collected during oocyte retrieval after ovarian stimulation
- Fertilization Rate [ Time Frame: 4 weeks ]Number of fertilized oocytes out of the total number that were mature
- Blastulation Rate [ Time Frame: 4 weeks ]Number of blastocysts that developed out of the total number of day three embryo
- Clinical Pregnancy Rate [ Time Frame: 6 weeks ]Number of ultrasound confirmed intrauterine pregnancies out of the total ovarian stimulation cycles for in vitro fertilization
- Cancellation Rate [ Time Frame: 2 weeks ]The number of ovarian stimulation cycles that were cancelled out of all the ovarian stimulation cycles started
- Ovarian Torsion [ Time Frame: 6 weeks ]Number of ovarian torsion cases that occurred out of the total ovarian stimulation cycles
- Live Birth Rate [ Time Frame: 10 months ]Number of Live Birth out of the total ovarian stimulation cycles for in vitro fertilization
- Treatment continuation rate [ Time Frame: 4 months ]Number of women who continue treatment after first cycle if not pregnant after the first cycle
| Ages Eligible for Study: | 18 Years to 43 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- First ovarian stimulation cycle for egg freezing or for in vitro fertilization
- English speaking/reading
Exclusion Criteria:
- Serious health conditions that limit amount of physical activity
- BMI>40
| Contact: Heather Huddleston, MD | 415-353-3040 | Heather.Huddleston@ucsf.edu | |
| Contact: Amy Wijekoon, MD | 415-353-7475 | Amy.Wijekoon@ucsf.edu |
| United States, California | |
| UCSF Medical Center at Mission Bay | Recruiting |
| San Francisco, California, United States, 94158 | |
| Principal Investigator: | Heather Huddleston, MD | University of California, San Francisco |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 26, 2019 | ||||||||
| First Posted Date ICMJE | June 28, 2019 | ||||||||
| Last Update Posted Date | August 27, 2020 | ||||||||
| Actual Study Start Date ICMJE | May 15, 2020 | ||||||||
| Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Physical Activity and Fertility Care Study | ||||||||
| Official Title ICMJE | Physical Activity and Fertility Care Study | ||||||||
| 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), Insufficiently active women (<75 minutes of vigorous exercise or <150 minutes of moderate exercise per week), or Inactive women (no moderate or vigorous 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, and the inactive group will be randomized to (E) increased or (F) 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Patients will be stratified into groups: "active," "insufficiently active," or "inactive" 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 |
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| Condition ICMJE | Infertility, Female | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
600 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 1, 2022 | ||||||||
| Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 43 Years (Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04002414 | ||||||||
| Other Study ID Numbers ICMJE | 19-28431 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | University of California, San Francisco | ||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University of California, San Francisco | ||||||||
| Verification Date | August 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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