search
Back to results

Physical Activity and Fertility Care Study (PACE)

Primary Purpose

Infertility, Female

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sufficient physical activity
Insufficient physical activity
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring Physical Activity, In Vitro Fertilization, Ovarian Stimulation, Exercise

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UCSF Medical Center at Mission BayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Usually Active- Decrease

Usually Active- Maintenance

Usually Insufficiently Inactive- Increase

Usually Insufficiently Inactive- Maintenance

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2019
Last Updated
August 8, 2022
Sponsor
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT04002414
Brief Title
Physical Activity and Fertility Care Study
Acronym
PACE
Official Title
Physical Activity and Fertility Care Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
Physical Activity, In Vitro Fertilization, Ovarian Stimulation, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usually Active- Decrease
Arm Type
Active Comparator
Arm Description
Participants who usually meet or exceed recommended levels of physical activity who will be asked to minimize activity during stimulation.
Arm Title
Usually Active- Maintenance
Arm Type
Experimental
Arm Description
Participants who usually meet or exceed recommended levels of physical activity who will be asked to maintain usual level of activity during stimulation.
Arm Title
Usually Insufficiently Inactive- Increase
Arm Type
Experimental
Arm Description
Participants who are usually inactive who will be asked to try to increase activity to the recommended level during stimulation.
Arm Title
Usually Insufficiently Inactive- Maintenance
Arm Type
Active Comparator
Arm Description
Participants who are usually inactive who will be asked to maintain inactivity during stimulation.
Intervention Type
Behavioral
Intervention Name(s)
Sufficient physical activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Insufficient physical activity
Intervention Description
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 Outcome Measure Information:
Title
Stress During Treatment based on daily end of day stress item
Description
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.
Time Frame
14 days
Title
Anxiety/Depression During Treatment based on Patient-Reported Outcomes Measurement Information System Short Form (PROMIS-SF) Depression 4a and Anxiety 4a
Description
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.
Time Frame
14 days
Title
Change in Stress during treatment based upon Perceived Stress Scale (PSS)-14
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of mature oocytes retrieved
Description
Number of mature oocytes collected during oocyte retrieval after ovarian stimulation
Time Frame
4 weeks
Title
Fertilization Rate
Description
Number of fertilized oocytes out of the total number that were mature
Time Frame
4 weeks
Title
Blastulation Rate
Description
Number of blastocysts that developed out of the total number of day three embryo
Time Frame
4 weeks
Title
Clinical Pregnancy Rate
Description
Number of ultrasound confirmed intrauterine pregnancies out of the total ovarian stimulation cycles for in vitro fertilization
Time Frame
6 weeks
Title
Cancellation Rate
Description
The number of ovarian stimulation cycles that were cancelled out of all the ovarian stimulation cycles started
Time Frame
2 weeks
Title
Ovarian Torsion
Description
Number of ovarian torsion cases that occurred out of the total ovarian stimulation cycles
Time Frame
6 weeks
Title
Live Birth Rate
Description
Number of Live Birth out of the total ovarian stimulation cycles for in vitro fertilization
Time Frame
10 months
Title
Treatment continuation rate
Description
Number of women who continue treatment after first cycle if not pregnant after the first cycle
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Huddleston, MD
Phone
415-353-3040
Email
Heather.Huddleston@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maren Shapiro, MD
Phone
415-353-7475
Email
Maren.Shapiro@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Huddleston, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Medical Center at Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Physical Activity and Fertility Care Study

We'll reach out to this number within 24 hrs