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临床试验/NCT01103973
NCT01103973已完成不适用

The Impact of Distress on the IVF Outcome

Boston IVF2 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2007年3月最近更新:
适应症
干预措施

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

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)

Placebo Comparator

For every three months in the study control subjects received $50 spa gift certificates.

干预措施: Control (Behavioral)

Mind/Body Program

Experimental

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)

研究者

发起方
Boston IVF
申办方类型
Other
责任方
Sponsor

研究点 (2)

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