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NCT Number: NCT07415850

The Effect of a Four-Week Hatha Yoga Intervention to Improve Quality of Life, Anxiety, and Depressive Symptoms in Individuals Undergoing Assisted Reproductive Technology (ART) Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Villanova University

Villanova, Pennsylvania, 19085, United States

Location contact

Mary B Murray, MEd, BSN, RN

CONTACT

[email protected]

4849955006

About this study

The lifetime prevalence of infertility globally is 17.5%, meaning that one in six people have experienced infertility at some point in their life.When unable to conceive, individuals and couples frequently turn to assisted reproductive technology services. Assisted reproductive technology (ART) treatments provide hope and reproductive opportunities to individuals and couples globally. Yet, ART treatments often cause emotional distress. The emotional and psychosocial distress that individuals undergoing ART care experience is comparable to the emotional experiences of women with cancer and other serious medical conditions. Substantial evidence illustrates the emotional burden of ART care and its negative impact on quality of life. In fact, this relentless emotional stress often causes women to stop ART treatments before achieving pregnancy, demonstrating that emotional factors do impact clinical outcomes.

Individuals in ART care have complex psychosocial needs along with biomedical ones. Because stress is so prominent in ART care and often contributes to discontinuing ART treatment, individuals may benefit from services aimed at reducing stress and anxiety and increasing quality of life. Psychosocial interventions, such as yoga, support the holistic needs of individuals in ART care. While previous studies and systematic reviews indicate that yoga for individuals in ART care is feasible, acceptable, and efficacious, there is a lack of rigorous studies on yoga interventions in ART care.

To address this critical need for health promotion and prevention of psychological distress, we will evaluate a four-week virtually delivered Hatha yoga intervention to support the psychosocial needs of individuals actively undergoing in vitro fertilization (IVF).

IVF is the most common type of ART treatment in the US and globally. Yoga is a mind-body practice, rooted in ancient Indian philosophy, which positively impacts physical and mental health and well-being. Hatha yoga, which is commonly practiced in the United States, incorporates breathing exercises, postures, and meditation.

A RCT with wait-list control group, using mixed effects analysis, will be conducted to achieve the following specific aims. 80 individuals actively undergoing IVF will be recruited for this study. Computer-generated block randomization will allocate 40 participants to the four-week virtually delivered Hatha yoga intervention group, and 40 participants will be allocated to the waitlist control group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Understand English
  • Scheduled for or currently undergoing an IVF cycle
  • Access to smartphone/computer/tablet and internet
  • Have a valid working email address

Exclusion criteria

  • 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
  • Individuals who score in the "severe depression" classification on the PHQ-9 (PHQ-9 score of 20-27)
  • Individuals endorsing suicidal ideation (answering yes on #9 of PHQ-9).

Treatment and study plan

Yoga

Behavioral

The intervention in this study is a four-week Hatha yoga intervention delivered virtually.

Other names: Hatha yoga

Primary outcomes

  1. 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.

    Time frame: From enrollment (Baseline) to the end of treatment at 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.

  2. 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.

    Time frame: From enrollment (Baseline) to the end of treatment at 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.

  3. Change from Baseline in Depressive symptom severity using the Patient Health Questionnaire (PHQ-9), measured at 4 weeks and 8 weeks.

    Time frame: From enrollment (Baseline) to the end of treatment at 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

  1. Determine if intervention effectiveness differs by individual characteristics, considering in-group differences in baseline characteristics and clinical information.

    Time frame: From enrollment to the end of treatment at 8 weeks.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Trout, PhD, CNM, FACNM, FAAN

CONTACT

[email protected]

Mary Beth Murray, MEd, BSN, RN

CONTACT

[email protected]

484-995-5006

Sponsors and collaborators

Lead sponsor

Villanova University

Other

Collaborators

  • American Society for Reproductive Medicine

Registry information

Official study title

The Effect of a Four-Week Hatha Yoga Intervention to Improve Quality of Life, Anxiety, and Depressive Symptoms in Individuals Undergoing Assisted Reproductive Technology (ART) Treatment: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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