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

February 16, 2017 updated by: Fertility Centers of Illinois

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 42 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
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).
6 weeks
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).
6 weeks
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 weeks
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).
6 weeks
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.
6 weeks
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.
6 weeks
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
6 weeks
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
6 weeks
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
6 weeks
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
6 weeks
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
6 weeks
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.
1 year
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.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fertility Centers of Illinois

Collaborators

Rush University Medical Center
Pulling Down the Moon, Holistic Health

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

March 1, 2017

Study Completion (ANTICIPATED)

April 1, 2017

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (ESTIMATE)

January 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15121505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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