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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. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: October 1, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
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: Triple (Participant, Care Provider, 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:

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 ]

Secondary Outcome Measures:
  • psychiatric evaluation questionnaires [ Time Frame: 2 months ]

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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00989053

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

Responsible Party: dr.Gabi Aisenberg Romano M.D, Tel aviv Sourasky medical center 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

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

Additional relevant MeSH terms:
Affective Symptoms
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents processed this record on September 21, 2017