Infertility, FemalePACENCT04002414
Physical Activity and Fertility Care Study
A study testing Sufficient physical activity and Insufficient physical activity in people with Infertility, Female, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Sufficient physical activity and Insufficient physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Serious health conditions that limit amount of physical activity
- BMI>40
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center at Mission Bay
San Francisco, California, 94158
About this 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.
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- Sufficient physical activity, Insufficient physical activity
- Keywords
- Physical Activity, In Vitro Fertilization, Ovarian Stimulation, Exercise
- Medical subject headings
- Infertility, Female, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufficient physical activityBehavioural
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 activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Sufficient physical activity |
| Usually Insufficiently Inactive- Maintenance | Active comparator | Participants who are usually inactive who will be asked to maintain inactivity during stimulation. Receives: Behavioral: Insufficient physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (8)
Number of mature oocytes retrieved
Number of mature oocytes collected during oocyte retrieval after ovarian stimulation
Measured: 4 weeks
Fertilization Rate
Number of fertilized oocytes out of the total number that were mature
Measured: 4 weeks
Blastulation Rate
Number of blastocysts that developed out of the total number of day three embryo
Measured: 4 weeks
Clinical Pregnancy Rate
Number of ultrasound confirmed intrauterine pregnancies out of the total ovarian stimulation cycles for in vitro fertilization
Measured: 6 weeks
Cancellation Rate
The number of ovarian stimulation cycles that were cancelled out of all the ovarian stimulation cycles started
Measured: 2 weeks
Ovarian Torsion
Number of ovarian torsion cases that occurred out of the total ovarian stimulation cycles
Measured: 6 weeks
Live Birth Rate
Number of Live Birth out of the total ovarian stimulation cycles for in vitro fertilization
Measured: 10 months
Treatment continuation rate
Number of women who continue treatment after first cycle if not pregnant after the first cycle
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start15 May 2020
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Huddleston, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002414
- Sponsor's protocol ID
- 19-28431
- Acronym
- PACE
- Status last verified
- Dec 2023
- First submitted
- 26 Jun 2019
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Fertility Care Study
- ClinicalTrials.gov ID
- NCT04002414
- Acronym / sponsor ID
- PACE / 19-28431
- Conditions
- Infertility, Female
- Keywords
- Physical Activity, In Vitro Fertilization, Ovarian Stimulation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usually Active- Decrease | Active comparator | Behavioral: Insufficient physical activityParticipants who usually meet or exceed recommended levels of physical activity who will be asked to minimize activity during stimulation. |
| Usually Active- Maintenance | Experimental | Behavioral: Sufficient physical activityParticipants who usually meet or exceed recommended levels of physical activity who will be asked to maintain usual level of activity during stimulation. |
| Usually Insufficiently Inactive- Increase | Experimental | Behavioral: Sufficient physical activityParticipants who are usually inactive who will be asked to try to increase activity to the recommended level during stimulation. |
| Usually Insufficiently Inactive- Maintenance | Active comparator | Behavioral: Insufficient physical activityParticipants who are usually inactive who will be asked to maintain inactivity during stimulation. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Serious health conditions that limit amount of physical activity
- BMI>40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufficient physical activityPhysical 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. | Behavioural | Usually Active- Maintenance, Usually Insufficiently Inactive- Increase |
| Insufficient physical activityPhysical 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. | Behavioural | Usually Active- Decrease, Usually Insufficiently Inactive- Maintenance |
Primary outcome
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.
8 secondary outcomes
Number of mature oocytes retrieved
Time frame: 4 weeks
Fertilization Rate
Time frame: 4 weeks
Blastulation Rate
Time frame: 4 weeks
Clinical Pregnancy Rate
Time frame: 6 weeks
Cancellation Rate
Time frame: 2 weeks
Ovarian Torsion
Time frame: 6 weeks
Live Birth Rate
Time frame: 10 months
Treatment continuation rate
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Huddleston, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sufficient physical activity and Insufficient physical activity in people with Infertility, Female, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress During Treatment based on daily end of day stress item (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.