Clinical trial NCT03031990: Stress and Fertility: How to Lower Stress When Trying to Conceive
Official title: Yoga and Infertility: The Impact of Yoga on Anxiety Reduction in Patients Undergoing in Vitro Fertilization or Elective Oocyte Freezing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Infertility, Female
Keywords: Yoga
Oocyte cryopreservation
In-vitro fertilization
Lead sponsor: Fertility Centers of Illinois
Sponsor class: OTHER
Collaborators: name: Pulling Down the Moon, Holistic Health
name: Rush University Medical Center
First posted: 2017-01-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Stress levels pre and post intervention between groups using STAI
timeFrame: 6 weeks
measure: Stress levels pre and post intervention between groups using FPI
timeFrame: 6 weeks
Secondary outcomes:
measure: Difference between mean pre and post STAI test scores between in person and online yoga for fertility programs
timeFrame: 6 weeks
measure: Difference between mean pre and post FPI test scores between in person and online yoga for fertility programs
timeFrame: 6 weeks
measure: Influence of ethnicity on baseline stress levels and reduction in stress using the STAI
timeFrame: 6 weeks
measure: Influence of ethnicity on baseline stress levels and reduction in stress using FPI
timeFrame: 6 weeks
measure: Influence of age on baseline stress levels and reduction in stress using STAI
timeFrame: 6 weeks
measure: Influence of age on baseline stress levels and reduction in stress using FPI
timeFrame: 6 weeks
measure: Influence of number of previous IVF failures on baseline stress levels and reductions in stress using STAI
timeFrame: 6 weeks
measure: Influence of number of previous IVF failures on baseline stress levels and reductions in stress using FPI
timeFrame: 6 weeks
measure: Influence of yoga participation on number of days required for ovarian stimulation
timeFrame: 6 weeks
measure: Influence of yoga participation on number of oocytes obtained
timeFrame: 6 weeks
measure: Influence of yoga participation on number of mature (M2) oocytes
timeFrame: 6 weeks
measure: Influence of yoga participation on fertilization rate
timeFrame: 6 weeks
measure: Influence of yoga participation on number of high quality embryos (as evidenced by embryologists embryo grading criteria)
timeFrame: 6 weeks
measure: Influence of yoga participation on rates of positive pregnancy test
timeFrame: 1 year
measure: Influence of yoga participation on clinical pregnancy rate
timeFrame: 1 year
measure: Influence of yoga participation on ongoing pregnancy/live birth rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Fertility Centers of Illinois
state: Illinois
Study officials:
affiliation: Fertility Centers of Illinois
name: Jennifer Hirshfeld, MD
role: STUDY_DIRECTOR
affiliation: Rush University Medical Center
name: Anne E Martini, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulling Down the Moon, Holistic Health
name: Beth Heller, MS
role: STUDY_DIRECTOR
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