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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)

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ClinicalTrials.gov Identifier: NCT00989053
Recruitment Status : Unknown
Verified October 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 2, 2009
Last Update Posted : October 2, 2009
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety In Vitro Fertilization Drug: escitalopram Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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.
Study Start Date : January 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. positive blood βHCG [ Time Frame: 2 months from date of signing informed consent ]

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


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: October 2, 2009
Last Verified: October 2009

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:
Depression
Affective Symptoms
Behavioral Symptoms
Citalopram
Serotonin Uptake Inhibitors
Dexetimide
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
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents