The Impact of Distress on the IVF Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Boston IVF
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Clinical Pregnancy Rates
研究概览
简要总结
Stress is a primary reason why in vitro fertilization (IVF) patients drop out of treatment, and it may have a detrimental impact on pregnancy rates, yet there is minimal published research on the efficacy of structured skills-based psychological interventions with assisted reproductive technology (ART) patients. The objective of this study is to determine if women who are randomized to a mind/body (MB) program prior to starting their first IVF cycle will have higher pregnancy rates than controls (C).
This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes 143 women ages 40 and below scheduled to undergo their first IVF cycle. Subjects are randomized via computer generated random numbers table to a 10 session mind/body program or a control group and followed for two IVF cycles. The primary outcome measure is clinical pregnancy rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female Boston IVF infertility patient
- •Age 21-40 years
- •Day 3 FSH level 12 mIU/ml or below
- •Day 3 E2 level 80 pg/ml or below
- •Using own eggs (not an egg donor)
- •Daily access to the internet
- •Able to read, understand, and sign the informed consent in English
排除标准
- •Prescription antipsychotic medication
- •Diagnosis of borderline or narcissistic personality disorder
- •Previous participation in a MB group
研究组 & 干预措施
Control (Spa Certificate)
For every three months in the study control subjects received $50 spa gift certificates.
干预措施: Control (Behavioral)
Mind/Body Program
Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
干预措施: Mind/Body Program (Behavioral)
结局指标
主要结局
Clinical Pregnancy Rates
时间窗: 1 year
Presence of normal fetal heart rate and fetal size at 7 weeks gestation.
次要结局
- Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)(1 year)
