About this trial
The goal of this clinical trial is to learn if a four-week yoga program works to improve quality of life in people undergoing IVF (In Vitro Fertilization). It will also learn if a four-week yoga program decreases anxiety and depression symptoms in people undergoing IVF.
The main questions it aims to answer are:
* Does a four-week yoga program effect quality of life, anxiety, and depression symptoms in people undergoing IVF? * Do the effects vary by individual characteristics of the people in the study?
Researchers will compare the yoga intervention group to routine care as usual.
Participants will:
* Participate in a weekly virtual yoga class for four weeks (total of four yoga classes), or follow routine care as usual while undergoing IVF. * Take three online surveys every 4 weeks. * Be involved in the study for 8 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Understand English
Scheduled for or currently undergoing an IVF cycle
Access to smartphone/computer/tablet and internet
Disqualifiers
Individuals who are Pregnant, or who become Pregnant during the study
Individuals undergoing non-IVF cycles (i.e. intrauterine insemination)
Individuals undergoing a frozen embryo transfer (FET) cycle
Individuals who are currently regularly practicing yoga
Trial design
Crossover
Treatments tested in this trial
Yoga
BehavioralThe intervention in this study is a four-week Hatha yoga intervention delivered virtually.
Treatment groups
Trial outcomes
Primary outcomes
Change from Baseline in Fertility Quality of Life using the FertiQoL, a validated 24-item self-report questionnaire, measured at 4 weeks and 8 weeks.
The change in Fertility Quality of Life will be measured using the Fertility Quality of Life scale (FertiQoL), a validated 24-item self-report questionnaire that assesses fertility quality of life, with total scores ranging from 0 to 100. Higher scores mean higher quality of life. Change in FertiQoL will be measured between the intervention group and wait-list control group at baseline, 4 weeks, and 8 weeks.
Change from Baseline in Anxiety symptom severity using the Hospital Anxiety and Depression Scale, Anxiety Subscale (HADS-A), measured at 4 weeks and 8 weeks.
The change in Anxiety symptom severity will be measured using the Hospital Anxiety and Depression Scale, Anxiety Subscale (HADS-A), a validated 7-item questionnaire with scores ranging from 0 to 21, where higher scores indicate greater anxiety severity. Change in HADS-A will be measured between the intervention group and wait-list control group at baseline, 4 weeks, and 8 weeks.
Change from Baseline in Depressive symptom severity using the Patient Health Questionnaire (PHQ-9), measured at 4 weeks and 8 weeks.
The change in Depressive symptom severity will be measured using the Patient Health Questionnaire (PHQ-9), a validated 9-item questionnaire with scores ranging from 0 to 27, where higher scores indicate greater depressive symptom severity. Change in PHQ-9 will be measured between the intervention group and wait-list control group at baseline, 4 weeks, and 8 weeks.
Secondary outcomes
Determine if intervention effectiveness differs by individual characteristics, considering in-group differences in baseline characteristics and clinical information.
Multivariate regression analysis will be conducted to identify any independent association between baseline characteristics and changes in scores. The equivalence of groups at baseline will be checked to control for differences if needed. Univariate descriptive statistics (distribution, measures of central tendency, and variability) will summarize baseline data.
Sponsors and contacts
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Villanova University
Lead sponsor
American Society for Reproductive Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options: