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

February 9, 2026 updated by: Villanova University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Villanova, Pennsylvania, United States, 19085
        • Villanova University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
After randomization, participants in this arm will receive the four-week yoga intervention.
Behavioral: Yoga
The intervention in this study is a four-week Hatha yoga intervention delivered virtually.
Other Names:
  • Hatha yoga
Active Comparator: Wait-List Control Group
After randomization, participants in this arm will receive routine care as usual for 4 weeks and then will receive the four-week yoga intervention.
Behavioral: Yoga
The intervention in this study is a four-week Hatha yoga intervention delivered virtually.
Other Names:
  • Hatha yoga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment (Baseline) to the end of treatment at 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.
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.
From enrollment (Baseline) to the end of treatment at 8 weeks.
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.
From enrollment (Baseline) to the end of treatment at 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Villanova University

Collaborators

American Society for Reproductive Medicine

Investigators

  • Study Director: Mary B Murray, MEd, BSN, RN, Villanova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 21, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY2026-6
  • ASRM Nursing/PA Research Award (Other Identifier: American Society for Reproductive Medicine (ASRM) Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be de-identified and is not planned to be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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