Back to resultsThe Effect of Selective Serotonin Reuptake Inhibitor (SSRI) Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing in Vitro Fertilization (IVF)
Primary Purpose
Depression, Anxiety, In Vitro Fertilization
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
escitalopram
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, anxiety, stress, antidepressant therapy, SSRI, infertility, in vitro fertilization (IVF), immunological factors, depressive and anxiety symptoms in women undergoing IVF treatment
Eligibility Criteria
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)
Sites / Locations
- Tel Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
escitalopram
placebo
Arm Description
Outcomes
Primary Outcome Measures
positive blood βHCG
Secondary Outcome Measures
psychiatric evaluation questionnaires
Full Information
NCT ID
NCT00989053
First Posted
October 1, 2009
Last Updated
October 1, 2009
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00989053
Brief Title
The Effect of Selective Serotonin Reuptake Inhibitor (SSRI) Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing in Vitro Fertilization (IVF)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, In Vitro Fertilization
Keywords
depression, anxiety, stress, antidepressant therapy, SSRI, infertility, in vitro fertilization (IVF), immunological factors, depressive and anxiety symptoms in women undergoing IVF treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
escitalopram
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Description
10 mg/d for a duration of 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 pill per day for 8 weeks
Primary Outcome Measure Information:
Title
positive blood βHCG
Time Frame
2 months from date of signing informed consent
Secondary Outcome Measure Information:
Title
psychiatric evaluation questionnaires
Time Frame
2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabi Aisenberg Romano, M.D
12. IPD Sharing Statement
Learn more about this trial
The Effect of Selective Serotonin Reuptake Inhibitor (SSRI) Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing in Vitro Fertilization (IVF)
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