Back to resultsThe Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women
Primary Purpose
Infertility, Stress
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional health services research trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- women between the ages of 18-35 without children undergoing IVF treatment
Exclusion Criteria:
- undergoing treatment for a DSM-IV axis I psychiatric illness.
Sites / Locations
- IVF Clinic Soroka UMC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
COGNITIVE BEHAVIORAL INTERVENTIONS
Arm Description
PSYCHOLOGICAL INTERVENTIONS TO INCLUDE, RELAXATION, STRESS REDUCTION, GUIDED IMAGERY, BREATHING EXERCISES
Outcomes
Primary Outcome Measures
pregnancy
Secondary Outcome Measures
DNA damage/ γH2AX
decreased stress
Full Information
NCT ID
NCT00685282
First Posted
May 25, 2008
Last Updated
February 11, 2013
Sponsor
Soroka University Medical Center
Collaborators
Ben-Gurion University of the Negev
1. Study Identification
Unique Protocol Identification Number
NCT00685282
Brief Title
The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women
Official Title
The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women Undergoing IVF Treatment.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
Collaborators
Ben-Gurion University of the Negev
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Stress
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COGNITIVE BEHAVIORAL INTERVENTIONS
Arm Type
Other
Arm Description
PSYCHOLOGICAL INTERVENTIONS TO INCLUDE, RELAXATION, STRESS REDUCTION, GUIDED IMAGERY, BREATHING EXERCISES
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
pregnancy
Time Frame
two years
Secondary Outcome Measure Information:
Title
DNA damage/ γH2AX
Time Frame
with in IVF cycle (2 months)
Title
decreased stress
Time Frame
two months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women between the ages of 18-35 without children undergoing IVF treatment
Exclusion Criteria:
undergoing treatment for a DSM-IV axis I psychiatric illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eitan Lunenfeld, PHD MD
Organizational Affiliation
Soroka UMC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julie Cwikel, PhD
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Orly Sarid, PhD
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iris Harvardi, PhD
Organizational Affiliation
Soroka UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVF Clinic Soroka UMC
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women
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