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

NCT07415850 | Not Yet Recruiting

• 2 other identifiers: IRB-FY2026-6ASRM Nursing/PA Research Award
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IVF; In Vitro Fertilization; Quality of Life (QOL); Anxiety; Depression and Anxiety Symptom; Assisted Reproduction Technologies; Yoga; Mental Health

Keywords

Fertilization in Vitro; Reproductive Techniques, Assisted; Quality of Life; Psychological Well-Being; Yoga; Mind-Body Therapies; Complementary Therapies

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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 Outcomes (1)

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

  From enrollment to the end of treatment at 8 weeks.

Study Arms (2)

Intervention Group

EXPERIMENTAL

After randomization, participants in this arm will receive the four-week yoga intervention.

Behavioral: Yoga

Wait-List Control Group

ACTIVE COMPARATOR

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

Interventions

Yoga BEHAVIORAL

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

Also known as: Hatha yoga

Intervention Group; Wait-List Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• American Society for Reproductive Medicine: collaborator
• Villanova University: lead

Study Sites (1)

Villanova University

Villanova, Pennsylvania, 19085, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Psychological Well-Being; Helping Behavior

Interventions

Yoga

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Social Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Mary B Murray, MEd, BSN, RN

  Villanova University

  STUDY DIRECTOR

Central Study Contacts

Mary Beth Murray, MEd, BSN, RN

CONTACT

484-995-5006; mmurra45@villanova.edu

Kimberly Trout, PhD, CNM, FACNM, FAAN

CONTACT

kimberly.trout@villanova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a randomized controlled trial (RCT) design with a wait-list control group.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 17, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)