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
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
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:

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


Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: Israel: Ministry of Health

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
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents processed this record on May 26, 2016