AnxietyNCT03031990
Stress and Fertility: How to Lower Stress When Trying to Conceive
A study testing In-person yoga for fertility group, Online yoga for fertility group and In person discussion only group in people with Anxiety and Infertility, Female, run by Fertility Centers of Illinois at 1 site in United States.
Trial summary
Psychological stress and its sources differ among the population and can be reduced in various ways. The practice of yoga has been shown to be an effective stress reducing agent. IVF processes have also been shown to increase stress levels, particularly in patients with multiple failed IVF cycles. Read more about this study
- Who is it for?
- Ages 24 to 42 years, women only
- Conditions the study is for
- Anxiety, Infertility, Female
- What is being tested?
- In-person yoga for fertility group, Online yoga for fertility group and In person discussion only group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- History of one prior IVF failure and planning to undergo a subsequent IVF cycle at the Fertility Centers of Illinois (FCI) OR
- Patients undergoing elective egg freezing for fertility preservation at FCI
- Deemed medically able to perform basic, gentle yoga without injury
Who cannot join
- Other medical problems that preclude yoga participation (though may be eligible for control group participation)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fertility Centers of Illinois
Chicago, Illinois, 60610
Jennifer Hirshfeld-Cytron, MD, 708-633-1999, Jennifer.hirshfeld-cytron@integramed.com
Sue Jasulaitis, RN, (847) 916-6297, sue.jasulaitis@integramed.com
About this study
Official title: Yoga and Infertility: The Impact of Yoga on Anxiety Reduction in Patients Undergoing in Vitro Fertilization or Elective Oocyte Freezing
Psychological stress and its sources differ among the population and can be reduced in various ways. The practice of yoga has been shown to be an effective stress reducing agent. IVF processes have also been shown to increase stress levels, particularly in patients with multiple failed IVF cycles. Less is known about stress levels in patients undergoing elective egg freezing for fertility preservation. The investigators demonstrated in a pilot project that yoga postures with a yoga focused discussion session decreases stress in infertility patients compared to controls. The goal of this study is to further explore the capability of yoga practice to reduce stress in a specific subset of infertility patients, those with a history of at least one failed IVF cycle and those undergoing elective oocyte cryopreservation. Additionally, the investigators are aiming to understand which aspect of the intervention (discussion vs. yoga) had the most impact and whether route of administration of the intervention (in person vs online) effects results.
Read the detailed description
Although stress is likely not a cause of infertility, research has shown negative effects of psychological stress on in vitro fertilization (IVF) outcomes. IVF processes have also been shown to increase stress in infertility patients. Patients that have had failed at IVF cycles are noted to have more stress. The practice of elective egg freezing is relatively new and little is known on the psychological wellbeing of these patients as they start ovarian stimulation for egg freezing. The practice of yoga has been shown to be an effective stress reducing agent. The investigators demonstrated in a pilot project that yoga postures coupled with a yoga focused discussion session decreases stress in infertility patients compared to controls. Therefore, the purpose of this study is to further explore this relationship and determine which aspect of the intervention had the most impact.
Participants will include women with a history of at least one IVF failure or women undergoing fertility preservation for elective egg freezing. The participants who elect to include yoga as part of their infertility treatments will self select one of three treatment groups: 1) In person yoga + discussion; 2) online yoga + discussion; 3) In person discussion only. The investigators will also recruit non-yoga participators as a control group.
The yoga participants and controls will be asked to fill out two questionnaires: The State-Trait Anxiety Inventory (STAI) and the Fertility Problem Inventory (FPI). STAI is a widely used measure of trait anxiety (a person's disposition towards being anxious over time) and state anxiety (how anxious a person feels at the present time). It is a 40-question survey that uses a 4-point Likert scale per question. A score of 20 corresponds to low anxiety and a score of 80 corresponds to high anxiety. It has been shown that higher anxiety scores exist in the infertility population. Mean STAI scores in the infertility population range between 30-50. The FPI is used as another tool for assessing a person's state anxiety and has been found to better discriminate between general stress and infertility-related stress. Participants will complete these at the beginning of participation and then again six weeks later. The design of the study will include a pre-test and post-test analysis.
The primary outcome is to determine whether stress reduction is greater in those women that participate in the yoga postures and discussion group when compared to those in the discussion only group or controls. The secondary hypothesis is that reduction in stress will be equivalent between online and in-person participators. Additional outcomes include an assessment of whether age or other demographic factors influence baseline stress levels or reduction in stress. The investigators also plan to examine whether the yoga participation has any influence on ovarian stimulation or pregnancy outcomes. Therefore, baseline patient demographic characteristics, clinical outcomes regarding ovarian stimulation as well as future pregnancy outcomes will also be collected.
The investigators plan to recruit at least 150 participants who are currently undergoing in-vitro fertilization (IVF) at Fertility Centers of Illinois (FCI) and 150 patients undergoing elective egg freezing for fertility preservation at FCI. Those 150 patients will then be further subdivided into one of the three treatment groups mentioned above or the control group.
Before starting the study, the participants interested in a treatment group involving yoga postures will be evaluated including a review of medical history and an assessment of ability to perform basic, gentle yoga without injury. All interventions will occur once weekly for a total of six weeks. The participant will be expected to participate in at least five of the six sessions in order to complete the study. If the participant is in the in person yoga + discussion group, she will complete a Yoga for Fertility class Pulling Down the Moon: An Integrative Center for Fertility which consists of a 30 minute discussion session followed by a 60 minute Vinyasa style yoga class. If the participant is in the online yoga + discussion group, she will attend an online webinar of the Yoga for Fertility class and engage in a home yoga practice with the Pulling Down the Moon Yoga DVD. If the participant is in the discussion only group, she will attend an in-person 30 minute discussion session at Pulling Down the Moon.
The investigators will be using paired t-tests to compare mean pre-test and post-test scores between groups and logistic regressions to evaluate the secondary outcomes.
- Conditions
- Anxiety, Infertility, Female
- Being tested
- In-person yoga for fertility group, Online yoga for fertility group, In person discussion only group
- Keywords
- Yoga, Oocyte cryopreservation, In-vitro fertilization
- Medical subject headings
- Anxiety Disorders, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person yoga for fertility groupBehavioural
The participants in this group will complete the Yoga for Fertility class at Pulling Down the Moon: An Integrative Center for Fertility. This consists of a 30 minute discussion session followed by a 60 minute Vinyasa style yoga class one time a week for a total of 6 weeks. Participants must attend at least 5 out of the 6 sessions to be included in the analysis.
Online yoga for fertility groupBehavioural
The participants in this group will complete an online webinar of the Yoga for Fertility class and engage in a home yoga practice with the Pulling Down the Moon Yoga DVD. This will occur one time a week for a total of 6 weeks. Participants must complete at least 5 out of the 6 sessions to be included in the analysis.
In person discussion only groupBehavioural
The participants in this group will attend an in-person 30 minute discussion session at Pulling Down the Moon. This will occur one time a week for a total of 6 weeks. Participants must complete at least 5 out of the 6 sessions to be included in the analysis.
| Study group | Role | What they receive |
|---|---|---|
| Yoga intervention | Experimental | The participants who elect to include yoga as part of their infertility treatments will self select one of three groups: 1) In person yoga for fertility group; 2) Online yoga for fertility group; 3) In person discussion only group Receives: Behavioral: In-person yoga for fertility group; Behavioral: Online yoga for fertility group; Behavioral: In person discussion only group |
| Control | No intervention | These are patients that have a history of IVF failure or who are undergoing elective egg freezing who elect to be included in the study but are not interested in including yoga as a part of their treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress levels pre and post intervention between groups using STAI
Will evaluate by comparing mean pre and post test scores for the State-Trait Anxiety Inventory (STAI) between groups to determine which treatment option produced highest reductions in anxiety. The STAI is a 40 question questionnaire scored on a point scale from 20-80.
Measured: 6 weeks
Stress levels pre and post intervention between groups using FPI
Will evaluate by comparing mean pre and post test scores for the The Fertility Problem Inventory (FPI) between groups to determine which treatment option produced highest reductions in anxiety. The FPI is a 46 question questionnaire scored by generating a composite score from five sub scale scores.
Measured: 6 weeks
Secondary outcomes (16)
Difference between mean pre and post STAI test scores between in person and online yoga for fertility programs
Will compare mean pre and post test scores on STAI between the in person and online yoga for fertility groups to determine whether the reduction in stress was greater in one versus the other.
Measured: 6 weeks
Difference between mean pre and post FPI test scores between in person and online yoga for fertility programs
Will compare mean pre and post test scores on FPI between the in person and online yoga for fertility groups to determine whether the reduction in stress was greater in one versus the other.
Measured: 6 weeks
Influence of ethnicity on baseline stress levels and reduction in stress using the STAI
Will compare mean pre and post test scores on STAI between various ethnic groups (1=American Indian/Native American, 2=Arab, 3=Asian/Pacific Islander, 4=Black/African American, 5=Caucasian/White, 6=Hispanic/Latino, 7=Multiracial, 8=Other, 9=Prefer not to answer).
Measured: 6 weeks
Influence of ethnicity on baseline stress levels and reduction in stress using FPI
Will compare mean pre and post test scores on FPI between various ethnic groups (1=American Indian/Native American, 2=Arab, 3=Asian/Pacific Islander, 4=Black/African American, 5=Caucasian/White, 6=Hispanic/Latino, 7=Multiracial, 8=Other, 9=Prefer not to answer).
Measured: 6 weeks
Influence of age on baseline stress levels and reduction in stress using STAI
Will compare mean pre and post test scores on STAI across ages (ranging 24-42).
Measured: 6 weeks
Influence of age on baseline stress levels and reduction in stress using FPI
Will compare mean pre and post test scores on FPI across ages (ranging 24-42).
Measured: 6 weeks
Influence of number of previous IVF failures on baseline stress levels and reductions in stress using STAI
Will compare mean pre and post test scores on STAI between participants when grouped based on the number of prior IVF failures.
Measured: 6 weeks
Influence of number of previous IVF failures on baseline stress levels and reductions in stress using FPI
Will compare mean pre and post test scores on FPI between participants when grouped based on the number of prior IVF failures.
Measured: 6 weeks
Influence of yoga participation on number of days required for ovarian stimulation
Will compare the above outcome between treatment groups as well as to the control group
Measured: 6 weeks
Influence of yoga participation on number of oocytes obtained
Will compare the above outcome between treatment groups as well as to the control group
Measured: 6 weeks
Influence of yoga participation on number of mature (M2) oocytes
Will compare the above outcome between treatment groups as well as to the control group
Measured: 6 weeks
Influence of yoga participation on fertilization rate
Will compare the above outcome between treatment groups as well as to the control group
Measured: 6 weeks
Influence of yoga participation on number of high quality embryos (as evidenced by embryologists embryo grading criteria)
Will compare the above outcome between treatment groups as well as to the control group
Measured: 6 weeks
Influence of yoga participation on rates of positive pregnancy test
Will follow patients who achieve pregnancy in cycle following intervention and track pregnancy outcomes to determine if there was a difference in outcomes between treatment and control groups.
Measured: 1 year
Influence of yoga participation on clinical pregnancy rate
Will follow patients who achieve pregnancy in cycle following intervention and track pregnancy outcomes to determine if there was a difference in outcomes between treatment and control groups.
Measured: 1 year
Influence of yoga participation on ongoing pregnancy/live birth rate
Will follow patients who achieve pregnancy in cycle following intervention and track pregnancy outcomes to determine if there was a difference in outcomes between treatment and control groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fertility Centers of Illinois
- Sponsor type
- University, hospital or other
- Collaborators
- Pulling Down the Moon, Holistic Health, Rush University Medical Center
- Responsible party
- Sponsor
- Investigators
- Jennifer Hirshfeld, MD, Study director, Fertility Centers of IllinoisAnne E Martini, DO, Principal investigator, Rush University Medical CenterBeth Heller, MS, Study director, Pulling Down the Moon, Holistic Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031990
- Sponsor's protocol ID
- 15121505
- Status last verified
- Feb 2017
- First submitted
- 4 Jan 2017
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jasani S, Heller B, Jasulaitis S, Davidson M, Cytron JH. Impact of a Structured Yoga Program on Anxiety in Infertility Patients: A Feasibility Study. JFIV Reprod Med Genet 4: 183, 2016.
Domar AD, Zuttermeister PC, Friedman R. The psychological impact of infertility: a comparison with patients with other medical conditions. J Psychosom Obstet Gynaecol. 1993;14 Suppl:45-52.
PubMed 8142988Sanders KA, Bruce NW. Psychosocial stress and treatment outcome following assisted reproductive technology. Hum Reprod. 1999 Jun;14(6):1656-62. doi: 10.1093/humrep/14.6.1656.
PubMed 10357996Ebbesen SM, Zachariae R, Mehlsen MY, Thomsen D, Hojgaard A, Ottosen L, Petersen T, Ingerslev HJ. Stressful life events are associated with a poor in-vitro fertilization (IVF) outcome: a prospective study. Hum Reprod. 2009 Sep;24(9):2173-82. doi: 10.1093/humrep/dep185. Epub 2009 May 22.
PubMed 19465459Domar AD, Gross J, Rooney K, Boivin J. Exploratory randomized trial on the effect of a brief psychological intervention on emotions, quality of life, discontinuation, and pregnancy rates in in vitro fertilization patients. Fertil Steril. 2015 Aug;104(2):440-51.e7. doi: 10.1016/j.fertnstert.2015.05.009. Epub 2015 Jun 13.
PubMed 26072382Lawson AK, Klock SC, Pavone ME, Hirshfeld-Cytron J, Smith KN, Kazer RR. Prospective study of depression and anxiety in female fertility preservation and infertility patients. Fertil Steril. 2014 Nov;102(5):1377-84. doi: 10.1016/j.fertnstert.2014.07.765. Epub 2014 Aug 22.
PubMed 25154674Oron G, Allnutt E, Lackman T, Sokal-Arnon T, Holzer H, Takefman J. A prospective study using Hatha Yoga for stress reduction among women waiting for IVF treatment. Reprod Biomed Online. 2015 May;30(5):542-8. doi: 10.1016/j.rbmo.2015.01.011. Epub 2015 Feb 3.
PubMed 25779021Domar AD, Rooney KL, Wiegand B, Orav EJ, Alper MM, Berger BM, Nikolovski J. Impact of a group mind/body intervention on pregnancy rates in IVF patients. Fertil Steril. 2011 Jun;95(7):2269-73. doi: 10.1016/j.fertnstert.2011.03.046. Epub 2011 Apr 15.
PubMed 21496800Khalsa HK. Yoga: an adjunct to infertility treatment. Fertil Steril. 2003 Oct;80 Suppl 4:46-51. doi: 10.1016/s0015-0282(03)01138-5.
PubMed 14568288Galhardo A, Cunha M, Pinto-Gouveia J. Mindfulness-Based Program for Infertility: efficacy study. Fertil Steril. 2013 Oct;100(4):1059-67. doi: 10.1016/j.fertnstert.2013.05.036. Epub 2013 Jun 27.
PubMed 23809500Newham JJ, Westwood M, Aplin JD, Wittkowski A. State-trait anxiety inventory (STAI) scores during pregnancy following intervention with complementary therapies. J Affect Disord. 2012 Dec 15;142(1-3):22-30. doi: 10.1016/j.jad.2012.04.027. Epub 2012 Sep 7.
PubMed 22959685Newton CR, Sherrard W, Glavac I. The Fertility Problem Inventory: measuring perceived infertility-related stress. Fertil Steril. 1999 Jul;72(1):54-62. doi: 10.1016/s0015-0282(99)00164-8.
PubMed 10428148
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga and Infertility: The Impact of Yoga on Anxiety Reduction in Patients Undergoing in Vitro Fertilization or Elective Oocyte Freezing
- ClinicalTrials.gov ID
- NCT03031990
- Acronym / sponsor ID
- 15121505
- Conditions
- Anxiety, Infertility, Female
- Keywords
- Yoga, Oocyte cryopreservation, In-vitro fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fertility Centers of IllinoisUniversity, hospital or other
- Collaborators
- Pulling Down the Moon, Holistic Health, Rush University Medical Center
- Study start
- Jan 2017
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- 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.
Psychological stress and its sources differ among the population and can be reduced in various ways. The practice of yoga has been shown to be an effective stress reducing agent. IVF processes have also been shown to increase stress levels, particularly in patients with multiple failed IVF cycles. Less is known about stress levels in patients undergoing elective egg freezing for fertility preservation. The investigators demonstrated in a pilot project that yoga postures with a yoga focused discussion session decreases stress in infertility patients compared to controls. The goal of this study is to further explore the capability of yoga practice to reduce stress in a specific subset of infertility patients, those with a history of at least one failed IVF cycle and those undergoing elective oocyte cryopreservation. Additionally, the investigators are aiming to understand which aspect of the intervention (discussion vs. yoga) had the most impact and whether route of administration of the intervention (in person vs online) effects results.
Detailed description
Although stress is likely not a cause of infertility, research has shown negative effects of psychological stress on in vitro fertilization (IVF) outcomes. IVF processes have also been shown to increase stress in infertility patients. Patients that have had failed at IVF cycles are noted to have more stress. The practice of elective egg freezing is relatively new and little is known on the psychological wellbeing of these patients as they start ovarian stimulation for egg freezing. The practice of yoga has been shown to be an effective stress reducing agent. The investigators demonstrated in a pilot project that yoga postures coupled with a yoga focused discussion session decreases stress in infertility patients compared to controls. Therefore, the purpose of this study is to further explore this relationship and determine which aspect of the intervention had the most impact.
Participants will include women with a history of at least one IVF failure or women undergoing fertility preservation for elective egg freezing. The participants who elect to include yoga as part of their infertility treatments will self select one of three treatment groups: 1) In person yoga + discussion; 2) online yoga + discussion; 3) In person discussion only. The investigators will also recruit non-yoga participators as a control group.
The yoga participants and controls will be asked to fill out two questionnaires: The State-Trait Anxiety Inventory (STAI) and the Fertility Problem Inventory (FPI). STAI is a widely used measure of trait anxiety (a person's disposition towards being anxious over time) and state anxiety (how anxious a person feels at the present time). It is a 40-question survey that uses a 4-point Likert scale per question. A score of 20 corresponds to low anxiety and a score of 80 corresponds to high anxiety. It has been shown that higher anxiety scores exist in the infertility population. Mean STAI scores in the infertility population range between 30-50. The FPI is used as another tool for assessing a person's state anxiety and has been found to better discriminate between general stress and infertility-related stress. Participants will complete these at the beginning of participation and then again six weeks later. The design of the study will include a pre-test and post-test analysis.
The primary outcome is to determine whether stress reduction is greater in those women that participate in the yoga postures and discussion group when compared to those in the discussion only group or controls. The secondary hypothesis is that reduction in stress will be equivalent between online and in-person participators. Additional outcomes include an assessment of whether age or other demographic factors influence baseline stress levels or reduction in stress. The investigators also plan to examine whether the yoga participation has any influence on ovarian stimulation or pregnancy outcomes. Therefore, baseline patient demographic characteristics, clinical outcomes regarding ovarian stimulation as well as future pregnancy outcomes will also be collected.
The investigators plan to recruit at least 150 participants who are currently undergoing in-vitro fertilization (IVF) at Fertility Centers of Illinois (FCI) and 150 patients undergoing elective egg freezing for fertility preservation at FCI. Those 150 patients will then be further subdivided into one of the three treatment groups mentioned above or the control group.
Before starting the study, the participants interested in a treatment group involving yoga postures will be evaluated including a review of medical history and an assessment of ability to perform basic, gentle yoga without injury. All interventions will occur once weekly for a total of six weeks. The participant will be expected to participate in at least five of the six sessions in order to complete the study. If the participant is in the in person yoga + discussion group, she will complete a Yoga for Fertility class Pulling Down the Moon: An Integrative Center for Fertility which consists of a 30 minute discussion session followed by a 60 minute Vinyasa style yoga class. If the participant is in the online yoga + discussion group, she will attend an online webinar of the Yoga for Fertility class and engage in a home yoga practice with the Pulling Down the Moon Yoga DVD. If the participant is in the discussion only group, she will attend an in-person 30 minute discussion session at Pulling Down the Moon.
The investigators will be using paired t-tests to compare mean pre-test and post-test scores between groups and logistic regressions to evaluate the secondary outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga intervention | Experimental | Behavioral: In-person yoga for fertility group, Behavioral: Online yoga for fertility group, Behavioral: In person discussion only groupThe participants who elect to include yoga as part of their infertility treatments will self select one of three groups: 1) In person yoga for fertility group; 2) Online yoga for fertility group; 3) In person discussion only group |
| Control | No intervention | –These are patients that have a history of IVF failure or who are undergoing elective egg freezing who elect to be included in the study but are not interested in including yoga as a part of their treatment. |
Who may qualify
- Ages
- 24 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History of one prior IVF failure and planning to undergo a subsequent IVF cycle at the Fertility Centers of Illinois (FCI) OR
- Patients undergoing elective egg freezing for fertility preservation at FCI
- Deemed medically able to perform basic, gentle yoga without injury
Key exclusion criteria (1 listed)
- Other medical problems that preclude yoga participation (though may be eligible for control group participation)
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 |
|---|---|---|
| In-person yoga for fertility groupThe participants in this group will complete the Yoga for Fertility class at Pulling Down the Moon: An Integrative Center for Fertility. This consists of a 30 minute discussion session followed by a 60 minute Vinyasa style yoga class one time a week for a total of 6 weeks. Participants must attend at least 5 out of the 6 sessions to be included in the analysis. | Behavioural | Yoga intervention |
| Online yoga for fertility groupThe participants in this group will complete an online webinar of the Yoga for Fertility class and engage in a home yoga practice with the Pulling Down the Moon Yoga DVD. This will occur one time a week for a total of 6 weeks. Participants must complete at least 5 out of the 6 sessions to be included in the analysis. | Behavioural | Yoga intervention |
| In person discussion only groupThe participants in this group will attend an in-person 30 minute discussion session at Pulling Down the Moon. This will occur one time a week for a total of 6 weeks. Participants must complete at least 5 out of the 6 sessions to be included in the analysis. | Behavioural | Yoga intervention |
Primary outcome
Stress levels pre and post intervention between groups using STAI
Time frame: 6 weeks
Will evaluate by comparing mean pre and post test scores for the State-Trait Anxiety Inventory (STAI) between groups to determine which treatment option produced highest reductions in anxiety. The STAI is a 40 question questionnaire scored on a point scale from 20-80.
Stress levels pre and post intervention between groups using FPI
Time frame: 6 weeks
Will evaluate by comparing mean pre and post test scores for the The Fertility Problem Inventory (FPI) between groups to determine which treatment option produced highest reductions in anxiety. The FPI is a 46 question questionnaire scored by generating a composite score from five sub scale scores.
16 secondary outcomes
Difference between mean pre and post STAI test scores between in person and online yoga for fertility programs
Time frame: 6 weeks
Difference between mean pre and post FPI test scores between in person and online yoga for fertility programs
Time frame: 6 weeks
Influence of ethnicity on baseline stress levels and reduction in stress using the STAI
Time frame: 6 weeks
Influence of ethnicity on baseline stress levels and reduction in stress using FPI
Time frame: 6 weeks
Influence of age on baseline stress levels and reduction in stress using STAI
Time frame: 6 weeks
Influence of age on baseline stress levels and reduction in stress using FPI
Time frame: 6 weeks
Influence of number of previous IVF failures on baseline stress levels and reductions in stress using STAI
Time frame: 6 weeks
Influence of number of previous IVF failures on baseline stress levels and reductions in stress using FPI
Time frame: 6 weeks
Influence of yoga participation on number of days required for ovarian stimulation
Time frame: 6 weeks
Influence of yoga participation on number of oocytes obtained
Time frame: 6 weeks
Influence of yoga participation on number of mature (M2) oocytes
Time frame: 6 weeks
Influence of yoga participation on fertilization rate
Time frame: 6 weeks
Influence of yoga participation on number of high quality embryos (as evidenced by embryologists embryo grading criteria)
Time frame: 6 weeks
Influence of yoga participation on rates of positive pregnancy test
Time frame: 1 year
Influence of yoga participation on clinical pregnancy rate
Time frame: 1 year
Influence of yoga participation on ongoing pregnancy/live birth rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- BackgroundJasani S, Heller B, Jasulaitis S, Davidson M, Cytron JH. Impact of a Structured Yoga Program on Anxiety in Infertility Patients: A Feasibility Study. JFIV Reprod Med Genet 4: 183, 2016.
- Background: PubMed 8142988Domar AD, Zuttermeister PC, Friedman R. The psychological impact of infertility: a comparison with patients with other medical conditions. J Psychosom Obstet Gynaecol. 1993;14 Suppl:45-52.
- Background: PubMed 10357996Sanders KA, Bruce NW. Psychosocial stress and treatment outcome following assisted reproductive technology. Hum Reprod. 1999 Jun;14(6):1656-62. doi: 10.1093/humrep/14.6.1656.
- Background: PubMed 19465459Ebbesen SM, Zachariae R, Mehlsen MY, Thomsen D, Hojgaard A, Ottosen L, Petersen T, Ingerslev HJ. Stressful life events are associated with a poor in-vitro fertilization (IVF) outcome: a prospective study. Hum Reprod. 2009 Sep;24(9):2173-82. doi: 10.1093/humrep/dep185. Epub 2009 May 22.
- Background: PubMed 26072382Domar AD, Gross J, Rooney K, Boivin J. Exploratory randomized trial on the effect of a brief psychological intervention on emotions, quality of life, discontinuation, and pregnancy rates in in vitro fertilization patients. Fertil Steril. 2015 Aug;104(2):440-51.e7. doi: 10.1016/j.fertnstert.2015.05.009. Epub 2015 Jun 13.
- Background: PubMed 25154674Lawson AK, Klock SC, Pavone ME, Hirshfeld-Cytron J, Smith KN, Kazer RR. Prospective study of depression and anxiety in female fertility preservation and infertility patients. Fertil Steril. 2014 Nov;102(5):1377-84. doi: 10.1016/j.fertnstert.2014.07.765. Epub 2014 Aug 22.
- Background: PubMed 25779021Oron G, Allnutt E, Lackman T, Sokal-Arnon T, Holzer H, Takefman J. A prospective study using Hatha Yoga for stress reduction among women waiting for IVF treatment. Reprod Biomed Online. 2015 May;30(5):542-8. doi: 10.1016/j.rbmo.2015.01.011. Epub 2015 Feb 3.
- Background: PubMed 21496800Domar AD, Rooney KL, Wiegand B, Orav EJ, Alper MM, Berger BM, Nikolovski J. Impact of a group mind/body intervention on pregnancy rates in IVF patients. Fertil Steril. 2011 Jun;95(7):2269-73. doi: 10.1016/j.fertnstert.2011.03.046. Epub 2011 Apr 15.
- Background: PubMed 14568288Khalsa HK. Yoga: an adjunct to infertility treatment. Fertil Steril. 2003 Oct;80 Suppl 4:46-51. doi: 10.1016/s0015-0282(03)01138-5.
- Background: PubMed 23809500Galhardo A, Cunha M, Pinto-Gouveia J. Mindfulness-Based Program for Infertility: efficacy study. Fertil Steril. 2013 Oct;100(4):1059-67. doi: 10.1016/j.fertnstert.2013.05.036. Epub 2013 Jun 27.
- Background: PubMed 22959685Newham JJ, Westwood M, Aplin JD, Wittkowski A. State-trait anxiety inventory (STAI) scores during pregnancy following intervention with complementary therapies. J Affect Disord. 2012 Dec 15;142(1-3):22-30. doi: 10.1016/j.jad.2012.04.027. Epub 2012 Sep 7.
- Background: PubMed 10428148Newton CR, Sherrard W, Glavac I. The Fertility Problem Inventory: measuring perceived infertility-related stress. Fertil Steril. 1999 Jul;72(1):54-62. doi: 10.1016/s0015-0282(99)00164-8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jennifer Hirshfeld, MD study director
Fertility Centers of Illinois
Anne E Martini, DO principal investigator
Rush University Medical Center
Beth Heller, MS study director
Pulling Down the Moon, Holistic Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person yoga for fertility group, Online yoga for fertility group and In person discussion only group in people with Anxiety and Infertility, Female, run by Fertility Centers of Illinois 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Hirshfeld, MD ((708) 633-1999, Jennifer.hirshfeld-cytron@integramed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress levels pre and post intervention between groups using STAI (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03031990, which also lists 12 linked publications.
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 20 Feb 2017.