The Effect of SSRI Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing In Vitro Fertilization for Unexplained Infertility - a Prospective Placebo-Controlled Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- positive blood βHCG
研究概览
简要总结
Women undergoing IVF show a high prevalence of depressive and anxiety symptoms. Furthermore, stress has harmful consequences on IVF and pregnancy outcomes. An immunological cascade was suggested to be involved in the process. Treatment in this setting is usually psychotherapy rather than pharmacotherapy, despite reasonable biological evidence suggesting beneficial influence of antidepressant therapy on pregnancy and well-being. Moreover, pharmacotherapy is more available and affordable than psychotherapy in the public health system. The investigators suggest to study the efficacy of antidepressant treatment in women undergoing IVF treatment, presenting with mild mood symptoms. The investigators hypothesize that treatment will result in a greater attenuation of affective symptoms, as well as in higher pregnancy success rates. Furthermore, certain immunological stress-reactive factors, may prove to be the biological mechanism underlying these effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 - 45 y.o.
- •A score higher then 45 on the Zung Self-Rating Anxiety Scale or a score higher then 16 on the Center for Epidemiologic Studies Depression Scale
- •Understanding of Hebrew
- •Willing to sign the informed consent
排除标准
- •An axis I DSM IVTR diagnosis other then a depressive, adjustment or anxiety disorder
- •Suicidal ideation
- •Current treatment with antidepressant medication
- •Physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.)
- •Alcoholism or drug abuse and dependence
- •Past severe side effects to SSRIs
- •Failed IVF (4 trials of good quality embryo reinstatement without achieving pregnancy)
研究组 & 干预措施
placebo
干预措施: placebo (Drug)
escitalopram
干预措施: escitalopram (Drug)
escitalopram
干预措施: placebo (Drug)
结局指标
主要结局
positive blood βHCG
时间窗: 2 months from date of signing informed consent
次要结局
- psychiatric evaluation questionnaires(2 months)
