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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 months for reporting.

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 more

Awards & 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