Physical Activity and Fertility Care Study

Infertility, Female Clinical Trial

— PACE  

Official title:

Physical Activity and Fertility Care Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002414
• Other study ID #: 19-28431
• Status: Completed
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The goal overall is to assess for safety and value of physical activity during fertility treatment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCSF Medical Center at Mission Bay	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days
Primary	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.	14 days
Primary	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.	4 weeks
Secondary	Number of mature oocytes retrieved	Number of mature oocytes collected during oocyte retrieval after ovarian stimulation	4 weeks
Secondary	Fertilization Rate	Number of fertilized oocytes out of the total number that were mature	4 weeks
Secondary	Blastulation Rate	Number of blastocysts that developed out of the total number of day three embryo	4 weeks
Secondary	Clinical Pregnancy Rate	Number of ultrasound confirmed intrauterine pregnancies out of the total ovarian stimulation cycles for in vitro fertilization	6 weeks
Secondary	Cancellation Rate	The number of ovarian stimulation cycles that were cancelled out of all the ovarian stimulation cycles started	2 weeks
Secondary	Ovarian Torsion	Number of ovarian torsion cases that occurred out of the total ovarian stimulation cycles	6 weeks
Secondary	Live Birth Rate	Number of Live Birth out of the total ovarian stimulation cycles for in vitro fertilization	10 months
Secondary	Treatment continuation rate	Number of women who continue treatment after first cycle if not pregnant after the first cycle	4 months