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临床试验/NCT01156324
NCT01156324撤回不适用

The Impact of an Online Stress Management Program on IVF Outcome

Boston IVF1 个研究点 分布在 1 个国家开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
Boston IVF
试验地点
1
主要终点
Clinical Pregnancy Rates

研究概览

简要总结

The goal of this study is to determine the impact of an online stress management program, which combines stress reduction and prevention strategies with personal care products/rituals which have relaxation properties, on pregnancy rates and psychological distress in women undergoing IVF for the first time.

详细描述

The relationship between stress and infertility has remained a subject of controversy for many years. Recent research indicates that stress has a strong negative impact on pregnancy rates in women undergoing in vitro fertilization (IVF). In addition, stress is the most common reason given by women who voluntarily terminate treatment.

In a recent study, women who participated in a group mind/body treatment program had higher pregnancy rates than control subjects. The impact of an online stress management program has never been studied in the infertile population. An online intervention would be far more accessible for many infertility patients.

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 patients
  • •day three FSH 12 or below
  • •day three estradiol 80 pg/ml or below
  • •able to read, understand and sign the informed consent in English
  • •using own eggs (not egg donor)
  • •willing and able to comply with study requirements
  • •must be well versed in using a personal computer and the internet and must have access to an internet-connected computer seven days per week

排除标准

  • •prescription antipsychotic medication
  • •previous diagnosis of borderline or narcissistic personality disorder
  • •previous or concurrent participation in a mind/body group

研究组 & 干预措施

Control

Placebo Comparator

Participants of the routine care control group will each receive a $50 gift certificate at the end of each IVF cycle for which they completed the questionnaires.

干预措施: Online Stress Management Group (Upliv) (Behavioral)

Online Stress Management Group (Upliv)

Experimental

Personalized online stress management program consisting of weekly sessions which each include relaxation exercises, stress management strategies, and lifestyle modification advice. Participants in Upliv will also be given a set of personal care products as part of the program.

干预措施: Control (Behavioral)

结局指标

主要结局

Clinical Pregnancy Rates

时间窗: 1 year

Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.

次要结局

  • Psychological Status(1 year)

研究者

发起方
Boston IVF
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alice D. Domar, PhD

Alice D. Domar, PhD

Boston IVF

研究点 (1)

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