跳至主要内容
临床试验/NCT03031990
NCT03031990Unknown不适用

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

Fertility Centers of Illinois2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Stress levels pre and post intervention between groups using STAI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
24 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Stress levels pre and post intervention between groups using STAI

时间窗: 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.

Stress levels pre and post intervention between groups using FPI

时间窗: 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.

次要结局

  • 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)
  • Difference between mean pre and post FPI test scores between in person and online yoga for fertility programs(6 weeks)
  • Influence of yoga participation on number of days required for ovarian stimulation(6 weeks)
  • Influence of ethnicity on baseline stress levels and reduction in stress using the STAI(6 weeks)
  • Influence of yoga participation on number of mature (M2) oocytes(6 weeks)
  • Influence of yoga participation on ongoing pregnancy/live birth rate(1 year)
  • Influence of age on baseline stress levels and reduction in stress using FPI(6 weeks)
  • Influence of yoga participation on number of oocytes obtained(6 weeks)
  • Influence of yoga participation on clinical pregnancy rate(1 year)
  • Difference between mean pre and post STAI test scores between in person and online yoga for fertility programs(6 weeks)
  • Influence of number of previous IVF failures on baseline stress levels and reductions in stress using STAI(6 weeks)
  • Influence of yoga participation on fertilization rate(6 weeks)
  • Influence of number of previous IVF failures on baseline stress levels and reductions in stress using FPI(6 weeks)
  • Influence of yoga participation on number of high quality embryos (as evidenced by embryologists embryo grading criteria)(6 weeks)
  • Influence of yoga participation on rates of positive pregnancy test(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验