The Effect of Selective Serotonin Reuptake Inhibitor (SSRI) Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing in Vitro Fertilization (IVF)

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Depression, Anxiety, In Vitro Fertilization

Intervention / Treatment
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* Drug: escitalopram
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: escitalopram<br> | Drug: escitalopram<br>* 10 mg/d for a duration of 8 weeks<br>Drug: placebo<br>* 1 pill per day for 8 weeks<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 1 pill per day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive blood βHCG |  | 2 months from date of signing informed consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychiatric evaluation questionnaires |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, anxiety, stress, antidepressant therapy, SSRI, infertility, in vitro fertilization (IVF), immunological factors, depressive and anxiety symptoms in women undergoing IVF treatment