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Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations and in Vitro Fertilization (IVF) Outcomes (IVF)

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ClinicalTrials.gov Identifier: NCT01032421
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : December 15, 2009
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
The current study's primary aim is to investigate the association between neuroendocrine fluctuations and mood disorders by monitoring mood states over distinct hormonal phases during in-vitro-fertilization (IVF) treatment. The secondary goal of this study is to explore psychological profiles and coping mechanisms of women undergoing IVF, and to identify the ones that are associated with successful psychological adaptation to the process and a successful biological outcome.

Condition or disease Intervention/treatment Phase
Mood Disorders Procedure: IVF procedure Phase 2

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations & IVF Outcomes
Study Start Date : January 2006
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders
U.S. FDA Resources

Group/Cohort Intervention/treatment
Observational (IVF is not done as part of the study)
Procedure: IVF procedure

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 42 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women admitted for their first or second IVF cycle, under the age of 42. Please see the detailed inclusion and exclusion criteria.

Inclusion Criteria:

  1. Admitted for their first or second IVF cycle;
  2. Demonstrated sufficient communication skills and level of understanding in the Hebrew language;
  3. signed an informed consent;
  4. Were under the age of 42;
  5. Were not suffering from endometriosis or male factor in patients who underwent testicular sperm extraction (TESE);
  6. Were not under psychotherapeutic or psychopharmacological treatment. The accepted indications for the IVF included a female factor, male factor or unexplained infertility.

Exclusion Criteria:

1. All others.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Michal Roll, tel aviv souraski medical center
ClinicalTrials.gov Identifier: NCT01032421     History of Changes
Other Study ID Numbers: 04-284
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009

Keywords provided by Tel-Aviv Sourasky Medical Center:
women admitted to the In Vitro Fertilization unit

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders