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

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01032421
Collaborator
(none)
100
Enrollment
23
Duration (Months)

Study Details

Study Description

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
  • Procedure: IVF procedure

Study Design

Study Type:
Observational
Anticipated 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 :
Jan 1, 2006
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
GNRH

Observational (IVF is not done as part of the study)

Procedure: IVF procedure

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tel-Aviv Sourasky Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01032421
    Other Study ID Numbers:
    • 04-284
    First Posted:
    Dec 15, 2009
    Last Update Posted:
    Dec 15, 2009
    Last Verified:
    Dec 1, 2009
    Keywords provided by , ,
    women admitted to the In Vitro Fertilization unit
    Additional relevant MeSH terms:
    Mood Disorders

    Study Results

    No Results Posted as of Dec 15, 2009