The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women
1 other identifier
interventional
70
1 country
1
Brief Summary
The general hypothesis of the research is that stress decreases fertility and that Cognitive Behavioral Therapy will reduce stress and increase fertility. Secondarily, we hypothesize that stress has a detrimental effect on DNA integrity and that stress reduction will reduce DNA damage in the cell.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2008
CompletedFirst Posted
Study publicly available on registry
May 28, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFebruary 12, 2013
February 1, 2013
2.3 years
May 25, 2008
February 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
pregnancy
two years
Secondary Outcomes (2)
DNA damage/ γH2AX
with in IVF cycle (2 months)
decreased stress
two months
Study Arms (1)
COGNITIVE BEHAVIORAL INTERVENTIONS
OTHERPSYCHOLOGICAL INTERVENTIONS TO INCLUDE, RELAXATION, STRESS REDUCTION, GUIDED IMAGERY, BREATHING EXERCISES
Interventions
The intervention (CBT) will focus on teaching specific skills which are adapted for women undergoing fertility related problems. Through the sessions the participants will learn relaxation techniques such as breathing, progressive relaxation, and guided imagery. Furthermore, suggestions for making healthier choices for coping and for releasing tension will be reviewed and discussed, with an emphasis on making healthy lifestyle changes with balance and perspective rather than in a punishing or depriving way. Each session will consist of: 20 minutes of stress-reduction behavioral relaxation, 40 minutes of cognitive restructuring and 30 minutes personal tailoring of the behavioral homework between each session.
Eligibility Criteria
You may qualify if:
- women between the ages of 18-35 without children undergoing IVF treatment
You may not qualify if:
- undergoing treatment for a DSM-IV axis I psychiatric illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IVF Clinic Soroka UMC
Beersheba, 84101, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eitan Lunenfeld, PHD MD
Soroka UMC
- PRINCIPAL INVESTIGATOR
Julie Cwikel, PhD
Ben-Gurion University of the Negev
- PRINCIPAL INVESTIGATOR
Orly Sarid, PhD
Ben-Gurion University of the Negev
- PRINCIPAL INVESTIGATOR
Iris Harvardi, PhD
Soroka UMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the IVF Unit at the Soroka Medical Center
Study Record Dates
First Submitted
May 25, 2008
First Posted
May 28, 2008
Study Start
November 1, 2008
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
February 12, 2013
Record last verified: 2013-02