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Stress and Fertility: How to Lower Stress When Trying to Conceive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031990
Recruitment Status : Unknown
Verified February 2017 by Fertility Centers of Illinois.
Recruitment status was:  Recruiting
First Posted : January 26, 2017
Last Update Posted : February 20, 2017
Sponsor:
Collaborators:
Pulling Down the Moon, Holistic Health
Rush University Medical Center
Information provided by (Responsible Party):
Fertility Centers of Illinois

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Anxiety Infertility, Female Behavioral: In-person yoga for fertility group Behavioral: Online yoga for fertility group Behavioral: In person discussion only group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Yoga and Infertility: The Impact of Yoga on Anxiety Reduction in Patients Undergoing in Vitro Fertilization or Elective Oocyte Freezing
Study Start Date : January 2017
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Infertility

Arm Intervention/treatment
Experimental: Yoga intervention
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
Behavioral: In-person yoga for fertility group
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.

Behavioral: Online yoga for fertility group
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.

Behavioral: In person discussion only group
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.

No Intervention: Control
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Difference between mean pre and post STAI test scores between in person and online yoga for fertility programs [ Time Frame: 6 weeks ]
    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.

  2. Difference between mean pre and post FPI test scores between in person and online yoga for fertility programs [ Time Frame: 6 weeks ]
    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.

  3. Influence of ethnicity on baseline stress levels and reduction in stress using the STAI [ Time Frame: 6 weeks ]
    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).

  4. Influence of ethnicity on baseline stress levels and reduction in stress using FPI [ Time Frame: 6 weeks ]
    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).

  5. Influence of age on baseline stress levels and reduction in stress using STAI [ Time Frame: 6 weeks ]
    Will compare mean pre and post test scores on STAI across ages (ranging 24-42).

  6. Influence of age on baseline stress levels and reduction in stress using FPI [ Time Frame: 6 weeks ]
    Will compare mean pre and post test scores on FPI across ages (ranging 24-42).

  7. Influence of number of previous IVF failures on baseline stress levels and reductions in stress using STAI [ Time Frame: 6 weeks ]
    Will compare mean pre and post test scores on STAI between participants when grouped based on the number of prior IVF failures.

  8. Influence of number of previous IVF failures on baseline stress levels and reductions in stress using FPI [ Time Frame: 6 weeks ]
    Will compare mean pre and post test scores on FPI between participants when grouped based on the number of prior IVF failures.

  9. Influence of yoga participation on number of days required for ovarian stimulation [ Time Frame: 6 weeks ]
    Will compare the above outcome between treatment groups as well as to the control group

  10. Influence of yoga participation on number of oocytes obtained [ Time Frame: 6 weeks ]
    Will compare the above outcome between treatment groups as well as to the control group

  11. Influence of yoga participation on number of mature (M2) oocytes [ Time Frame: 6 weeks ]
    Will compare the above outcome between treatment groups as well as to the control group

  12. Influence of yoga participation on fertilization rate [ Time Frame: 6 weeks ]
    Will compare the above outcome between treatment groups as well as to the control group

  13. Influence of yoga participation on number of high quality embryos (as evidenced by embryologists embryo grading criteria) [ Time Frame: 6 weeks ]
    Will compare the above outcome between treatment groups as well as to the control group

  14. Influence of yoga participation on rates of positive pregnancy test [ Time Frame: 1 year ]
    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.

  15. Influence of yoga participation on clinical pregnancy rate [ Time Frame: 1 year ]
    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.

  16. Influence of yoga participation on ongoing pregnancy/live birth rate [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   24 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Other medical problems that preclude yoga participation (though may be eligible for control group participation)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031990


Contacts
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Contact: Jennifer Hirshfeld, MD (708) 633-1999 Jennifer.hirshfeld-cytron@integramed.com
Contact: Anne E Martini, DO (847) 867-7081 anne_e_martini@rush.edu

Locations
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United States, Illinois
Fertility Centers of Illinois Recruiting
Chicago, Illinois, United States, 60610
Contact: Jennifer Hirshfeld-Cytron, MD    708-633-1999    Jennifer.hirshfeld-cytron@integramed.com   
Contact: Sue Jasulaitis, RN    (847) 916-6297    sue.jasulaitis@integramed.com   
Sub-Investigator: Anne E Martini, DO         
Sponsors and Collaborators
Fertility Centers of Illinois
Pulling Down the Moon, Holistic Health
Rush University Medical Center
Investigators
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Study Director: Jennifer Hirshfeld, MD Fertility Centers of Illinois
Principal Investigator: Anne E Martini, DO Rush University Medical Center
Study Director: Beth Heller, MS Pulling Down the Moon, Holistic Health
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.

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Responsible Party: Fertility Centers of Illinois
ClinicalTrials.gov Identifier: NCT03031990    
Other Study ID Numbers: 15121505
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fertility Centers of Illinois:
Yoga
Oocyte cryopreservation
In-vitro fertilization
Additional relevant MeSH terms:
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Infertility
Infertility, Female