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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-01-31

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.

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Detailed Description

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Conditions

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Depression Anxiety In Vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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escitalopram

Group Type ACTIVE_COMPARATOR

escitalopram

Intervention Type DRUG

10 mg/d for a duration of 8 weeks

placebo

Intervention Type DRUG

1 pill per day for 8 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

1 pill per day for 8 weeks

Interventions

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escitalopram

10 mg/d for a duration of 8 weeks

Intervention Type DRUG

placebo

1 pill per day for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Women 18 - 45 y.o.
2. 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
3. Understanding of Hebrew
4. Willing to sign the informed consent

Exclusion Criteria

1. An axis I DSM IVTR diagnosis other then a depressive, adjustment or anxiety disorder
2. Suicidal ideation
3. Current treatment with antidepressant medication
4. Physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.)
5. Alcoholism or drug abuse and dependence
6. Past severe side effects to SSRIs
7. Failed IVF (4 trials of good quality embryo reinstatement without achieving pregnancy)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No