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

Anxiety Clinical Trial

Official title:

Yoga and Infertility: The Impact of Yoga on Anxiety Reduction in Patients Undergoing in Vitro Fertilization or Elective Oocyte Freezing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03031990
• Other study ID #: 15121505
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2017
• Last updated: February 16, 2017
• Start date: January 2017
• Est. completion date: April 2017

Study information

• Verified date: February 2017
• Source: Fertility Centers of Illinois
• Contact: Jennifer Hirshfeld, MD
• Phone: (708) 633-1999
• Email: Jennifer.hirshfeld-cytron[@]integramed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 24 Years to 42 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Infertility
• Infertility, Female

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Fertility Centers of Illinois	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Fertility Centers of Illinois	Pulling Down the Moon, Holistic Health, Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (12)

Domar 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. — View Citation

Domar 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. — View Citation

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. — View Citation

Ebbesen SM, Zachariae R, Mehlsen MY, Thomsen D, Højgaard 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. — View Citation

Galhardo 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. — View Citation

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.

Khalsa HK. Yoga: an adjunct to infertility treatment. Fertil Steril. 2003 Oct;80 Suppl 4:46-51. — View Citation

Lawson 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. — View Citation

Newham 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. Review. — View Citation

Newton CR, Sherrard W, Glavac I. The Fertility Problem Inventory: measuring perceived infertility-related stress. Fertil Steril. 1999 Jul;72(1):54-62. — View Citation

Oron 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. — View Citation

Sanders KA, Bruce NW. Psychosocial stress and treatment outcome following assisted reproductive technology. Hum Reprod. 1999 Jun;14(6):1656-62. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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).	6 weeks
Secondary	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).	6 weeks
Secondary	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).	6 weeks
Secondary	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).	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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	6 weeks
Secondary	Influence of yoga participation on number of oocytes obtained	Will compare the above outcome between treatment groups as well as to the control group	6 weeks
Secondary	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	6 weeks
Secondary	Influence of yoga participation on fertilization rate	Will compare the above outcome between treatment groups as well as to the control group	6 weeks
Secondary	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	6 weeks
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year