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

Not Applicable

• Conditions: Depression; Anxiety; In Vitro Fertilization
• Interventions: Drug: escitalopram; Drug: placebo

• Registration Number: NCT00989053
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-01
• Last Update Submitted: 2009-10-01
• Study First Posted: 2009-10-02
• Last Update Posted: 2009-10-02
• Study Start: 2010-01
• Primary Completion: 2012-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
escitalopram	escitalopram	-
escitalopram	placebo	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
positive blood βHCG	2 months from date of signing informed consent

Secondary Outcome Measures

Name	Time	Method
psychiatric evaluation questionnaires	2 months

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel