Creating Affiliations, Learning, and Mindfulness for In Vitro Fertilization Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Change in female fertility patient quality of life score during IVF treatment cycle
研究概览
简要总结
The investigators have designed a psychoeducational group curriculum specifically for new in vitro fertilization (IVF) patients (both male and female) to improve their treatment knowledge, to allow them to engage more in their care, to offer a support network, to improve satisfaction, and to provide them with tools to help reduce their stress and anxiety while undergoing the IVF process. The investigators plan to have four to eight infertility patients and their partners participate in a group at a time, for which they will attend three 1-1.5 hour interactive sessions that are scheduled throughout their first IVF cycle. These sessions will provide additional time for discussion about treatment with providers, learning opportunities on topics of interest to fertility patients, and stress reduction techniques. They will do several surveys before and after the intervention for comparison, including assessment of quality of life, depression, anxiety, resilience, and a knowledge assessment. The investigators will also track the patients to see if they pursue additional treatment in the instance of a negative pregnancy test compared to patients undergoing the standard treatment. The investigators plan to recruit a control group that receives the standard of care treatment here at the University of Iowa.
详细描述
Patients and their partners will be randomized in a 2:1 fashion to two different treatment arms: A) standard of care in vitro fertilization (IVF) at the investigational institution as well as participating in an additional psychoeducational group or B) standard of care IVF at the investigational institution. The intervention group will consist of three additional evening visits for 1-1.5 hours per session. The sessions will include an interactive educational component addressing usual questions and concerns of IVF patients, such as reviewing common IVF myths, and also more information regarding treatment and technologies. Each session will also include teaching of coping strategies (such as awaiting the pregnancy test, how to cope with insensitive remarks from friends and family) as well as relaxation exercises, such as progressive muscle relaxation and deep breathing.
The patients will be consented at their new IVF visit and will take their initial assessments (FertiQoL, GAD-7, PHQ-9, the Connor-Davidson Resilience Scale, and a knowledge assessment) within 24 hours of the new visit. The patients will be assigned into groups based on when they are going through their IVF stimulations, so they will have similar experiences at similar times. Patients will take their final assessments on the third day after egg retrieval, regardless of group assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients starting their first in vitro fertilization cycle at the University of Iowa Hospitals and Clinics
排除标准
- •Patients who have already undergone in vitro fertilization treatment at any institution
- •Non-English speakers
- •Fertility preservation patients
- •Patients using donor oocytes, embryos, or sperm
- •Patients taking psychotropic medications for depression or anxiety that have had a dosing adjustment within 3 months of study enrollment
结局指标
主要结局
Change in female fertility patient quality of life score during IVF treatment cycle
时间窗: From enrollment to 2-4 days after oocyte retrieval
FertiQoL International (Fertility Quality of Life Questionnaire 2008), scored scale from 0-100, with higher values indicating a higher quality of life and low scores indicating a lower quality of life.
次要结局
- Change in male fertility patient quality of life score during IVF treatment cycle(From enrollment to 2-4 days after oocyte retrieval)
- Likelihood of continued IVF treatment in the instance of a negative pregnancy test(Three months after embryo transfer)
- Change in male Connor-Davidson Resilience Scale during IVF treatment cycle(From enrollment to 2-4 days after oocyte retrieval)
- Change in female GAD-7 score during IVF treatment cycle(From enrollment to 2-4 days after oocyte retrieval)
- Change in female Connor-Davidson Resilience Scale during IVF treatment cycle(From enrollment to 2-4 days after oocyte retrieval)
- Change in female knowledge assessment during IVF treatment cycle(From enrollment to 2-4 days after oocyte retrieval)
- Change in male PHQ-9 score during IVF treatment cycle(From enrollment to 2-4 days after oocyte retrieval)
- Change in male knowledge assessment during IVF treatment cycle(From enrollment to 2-4 days after oocyte retrieval)
- Change in female PHQ-9 score during IVF treatment cycle(From enrollment to 2-4 days after oocyte retrieval)
- Change in male GAD-7 score during IVF treatment cycle(From enrollment to 2-4 days after oocyte retrieval)
研究者
Rachel Whynott
Fellow Physician
University of Iowa