IVFNCT07415850
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 study testing Yoga in people with IVF and In Vitro Fertilization, run by Villanova University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- IVF, In Vitro Fertilization, Quality of Life (QOL)
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kimberly Trout, PhD, CNM, FACNM, FAAN contact
United States1 site
Villanova University
Villanova, Pennsylvania, 19085
Mary B Murray, MEd, BSN, RN, 4849955006, mmurra45@villanova.edu
About this study
Official 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
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:
Read more
- 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.
Read the 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.
- Conditions
- IVF, In Vitro Fertilization, Quality of Life (QOL), Anxiety, Depression and Anxiety Symptom, Assisted Reproduction Technologies
- Being tested
- Yoga
- Keywords
- Fertilization in Vitro, Reproductive Techniques, Assisted, Quality of Life, Psychological Well-Being, Yoga, Mind-Body Therapies, Complementary Therapies
- Medical subject headings
- Anxiety Disorders, Depression, Psychological Well-Being, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Also called Hatha yoga
The intervention in this study is a four-week Hatha yoga intervention delivered virtually.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | After randomization, participants in this arm will receive the four-week yoga intervention. Receives: 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. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: From enrollment to the end of treatment at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start21 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a randomized controlled trial (RCT) design with a wait-list control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Villanova University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Reproductive Medicine
- Responsible party
- Sponsor
- Investigators
- Mary B Murray, MEd, BSN, RN, Study director, Villanova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415850
- Sponsor's protocol ID
- IRB-FY2026-6
- Other IDs
- ASRM Nursing/PA Research Award
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be de-identified and is not planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07415850
- Acronym / sponsor ID
- IRB-FY2026-6
- Conditions
- IVF, In Vitro Fertilization, Quality of Life (QOL), Anxiety, Depression and Anxiety Symptom, Assisted Reproduction Technologies
- Keywords
- Fertilization in Vitro, Reproductive Techniques, Assisted, Quality of Life, Psychological Well-Being, Yoga, Mind-Body Therapies, Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Villanova UniversityUniversity, hospital or other
- Collaborators
- American Society for Reproductive Medicine
- Study start
- 21 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a randomized controlled trial (RCT) design with a wait-list control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: YogaAfter randomization, participants in this arm will receive the four-week yoga intervention. |
| Wait-List Control Group | Active comparator | Behavioral: YogaAfter randomization, participants in this arm will receive routine care as usual for 4 weeks and then will receive the four-week yoga intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaAlso: Hatha yogaThe intervention in this study is a four-week Hatha yoga intervention delivered virtually. | Behavioural | Intervention Group, Wait-List Control Group |
Primary outcome
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.
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.
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No. Data will be de-identified and is not planned to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly Trout, PhD, CNM, FACNM, FAAN contact
Mary B Murray, MEd, BSN, RN study director
Villanova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with IVF and In Vitro Fertilization, run by Villanova University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Beth Murray, MEd, BSN, RN (484-995-5006, mmurra45@villanova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.