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

Depression Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00989053
• Other study ID #: TASMC-09-GAR-078-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: October 1, 2009
• Last updated: October 1, 2009
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Affective Symptoms
• Anxiety
• Depression
• In Vitro Fertilization

Intervention

Drug:
• escitalopram
10 mg/d for a duration of 8 weeks
• placebo
1 pill per day for 8 weeks

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive blood ßHCG		2 months from date of signing informed consent	No
Secondary	psychiatric evaluation questionnaires		2 months	No