- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01032421
Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations and in Vitro Fertilization (IVF) Outcomes (IVF)
December 13, 2009 updated by: Tel-Aviv Sourasky Medical Center
Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations & IVF Outcomes
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 42 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
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.
Description
Inclusion Criteria:
- Admitted for their first or second IVF cycle;
- Demonstrated sufficient communication skills and level of understanding in the Hebrew language;
- signed an informed consent;
- Were under the age of 42;
- Were not suffering from endometriosis or male factor in patients who underwent testicular sperm extraction (TESE);
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
GNRH
Observational (IVF is not done as part of the study)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zaig I, Azem F, Schreiber S, Amit A, Litvin YG, Bloch M. Psychological response and cortisol reactivity to in vitro fertilization treatment in women with a lifetime anxiety or unipolar mood disorder diagnosis. J Clin Psychiatry. 2013 Apr;74(4):386-92. doi: 10.4088/JCP.12m07805.
- Bloch M, Azem F, Aharonov I, Ben Avi I, Yagil Y, Schreiber S, Amit A, Weizman A. GnRH-agonist induced depressive and anxiety symptoms during in vitro fertilization-embryo transfer cycles. Fertil Steril. 2011 Jan;95(1):307-9. doi: 10.1016/j.fertnstert.2010.07.1073.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
November 25, 2009
First Submitted That Met QC Criteria
December 13, 2009
First Posted (Estimate)
December 15, 2009
Study Record Updates
Last Update Posted (Estimate)
December 15, 2009
Last Update Submitted That Met QC Criteria
December 13, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-284
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.