Stress and Fertility: How to Lower Stress When Trying to Conceive
Yoga and Infertility: The Impact of Yoga on Anxiety Reduction in Patients Undergoing in Vitro Fertilization or Elective Oocyte Freezing
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Jan 2017
Shorter than P25 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
January 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedFebruary 20, 2017
February 1, 2017
2 months
January 4, 2017
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (16)
Difference between mean pre and post STAI test scores between in person and online yoga for fertility programs
6 weeks
Difference between mean pre and post FPI test scores between in person and online yoga for fertility programs
6 weeks
Influence of ethnicity on baseline stress levels and reduction in stress using the STAI
6 weeks
Influence of ethnicity on baseline stress levels and reduction in stress using FPI
6 weeks
Influence of age on baseline stress levels and reduction in stress using STAI
6 weeks
- +11 more secondary outcomes
Study Arms (2)
Yoga intervention
EXPERIMENTALThe 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 INTERVENTIONThese 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Other medical problems that preclude yoga participation (though may be eligible for control group participation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fertility Centers of Illinoislead
- Pulling Down the Moon, Holistic Healthcollaborator
- Rush University Medical Centercollaborator
Study Sites (1)
Fertility Centers of Illinois
Chicago, Illinois, 60610, United States
Related Publications (12)
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.
BACKGROUNDDomar 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.
PMID: 8142988BACKGROUNDSanders 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.
PMID: 10357996BACKGROUNDEbbesen 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.
PMID: 19465459BACKGROUNDDomar 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.
PMID: 26072382BACKGROUNDLawson 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.
PMID: 25154674BACKGROUNDOron 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.
PMID: 25779021BACKGROUNDDomar 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.
PMID: 21496800BACKGROUNDKhalsa HK. Yoga: an adjunct to infertility treatment. Fertil Steril. 2003 Oct;80 Suppl 4:46-51. doi: 10.1016/s0015-0282(03)01138-5.
PMID: 14568288BACKGROUNDGalhardo 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.
PMID: 23809500BACKGROUNDNewham 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.
PMID: 22959685BACKGROUNDNewton 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.
PMID: 10428148BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2017
First Posted
January 26, 2017
Study Start
January 1, 2017
Primary Completion
March 1, 2017
Study Completion
April 1, 2017
Last Updated
February 20, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share