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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00989053
First received: October 1, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Depression
Anxiety
In Vitro Fertilization
 Drug: escitalopram
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • positive blood βHCG [ Time Frame: 2 months from date of signing informed consent ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • psychiatric evaluation questionnaires [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: escitalopram Drug: escitalopram
10 mg/d for a duration of 8 weeks
Drug: placebo
1 pill per day for 8 weeks
Placebo Comparator: placebo Drug: placebo
1 pill per day for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989053

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Principal Investigator: Gabi Aisenberg Romano, M.D            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: dr.Gabi Aisenberg Romano M.D, Tel aviv Sourasky medical center
ClinicalTrials.gov Identifier: NCT00989053     History of Changes
Other Study ID Numbers: TASMC-09-GAR-078-CTIL
Study First Received: October 1, 2009
Last Updated: October 1, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
depression
anxiety
stress
antidepressant therapy
SSRI
 infertility
in vitro fertilization (IVF)
immunological factors
depressive and anxiety symptoms in women undergoing IVF treatment

Additional relevant MeSH terms:
Affective Symptoms
Anxiety Disorders
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Dexetimide
Citalopram
Serotonin Uptake Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on May 19, 2013