NCT01032421

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

1.9 years

First QC Date

November 25, 2009

Last Update Submit

December 13, 2009

Conditions

Keywords

women admitted to the In Vitro Fertilization unit

Study Arms (1)

GNRH

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

Procedure: IVF procedure

Interventions

IVF procedurePROCEDURE
GNRH

Eligibility Criteria

AgeUp to 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • \. All others.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 25, 2009

First Posted

December 15, 2009

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 15, 2009

Record last verified: 2009-12