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

This study has been completed.
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01032421
First received: November 25, 2009
Last updated: December 13, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Mood Disorders
 Procedure: IVF procedure
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations & IVF Outcomes

Resource links provided by NLM:

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

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

Estimated Enrollment: 100
Study Start Date: January 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
GNRH
Observational (IVF is not done as part of the study)
 Procedure: IVF procedure

  Eligibility

Ages Eligible for Study:   up to 42 Years
Genders 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.

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.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Tel-Aviv Sourasky Medical Center

Additional 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
Study First Received: November 25, 2009
Last Updated: December 13, 2009
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013