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Sufficient physical activity for Female Infertility (PACE Trial)
N/A
Waitlist Available
Led By Heather Huddleston, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if exercise during fertility treatment affects mental health and success rates. Women are asked to change their exercise routines, and their heart rates and mental health are checked regularly to see the impact.
Eligible Conditions
- Female Infertility
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anxiety/Depression During Treatment based on Patient-Reported Outcomes Measurement Information System Short Form (PROMIS-SF) Depression 4a and Anxiety 4a
Change in Stress during treatment based upon Perceived Stress Scale (PSS)-14
Stress During Treatment based on daily end of day stress item
Secondary study objectives
Blastulation Rate
Cancellation Rate
Clinical Pregnancy Rate
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Usually Insufficiently Inactive- IncreaseExperimental Treatment1 Intervention
Participants who are usually inactive who will be asked to try to increase activity to the recommended level during stimulation.
Group II: Usually Active- MaintenanceExperimental Treatment1 Intervention
Participants who usually meet or exceed recommended levels of physical activity who will be asked to maintain usual level of activity during stimulation.
Group III: Usually Active- DecreaseActive Control1 Intervention
Participants who usually meet or exceed recommended levels of physical activity who will be asked to minimize activity during stimulation.
Group IV: Usually Insufficiently Inactive- MaintenanceActive Control1 Intervention
Participants who are usually inactive who will be asked to maintain inactivity during stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sufficient physical activity
2020
N/A
~220
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,570 Previous Clinical Trials
15,175,314 Total Patients Enrolled
Heather Huddleston, MDPrincipal InvestigatorUniversity of California, San Francisco
6 Previous Clinical Trials
8,112 Total Patients Enrolled
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