The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women

The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women Undergoing IVF Treatment.

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Stress
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Beer Sheva, Israel, 84101
    • IVF Clinic Soroka UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: COGNITIVE BEHAVIORAL INTERVENTIONS; PSYCHOLOGICAL INTERVENTIONS TO INCLUDE, RELAXATION, STRESS REDUCTION, GUIDED IMAGERY, BREATHING EXERCISES

Behavioral: Cognitive Behavioral Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pregnancy	two years

Secondary Outcome Measures

Outcome Measure	Time Frame
DNA damage/ γH2AX	with in IVF cycle (2 months)
decreased stress	two months

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Collaborators: Ben-Gurion University of the Negev
• Investigators: 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 record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: May 25, 2008
• First Submitted That Met QC Criteria: May 25, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Estimate): February 12, 2013
• Last Update Submitted That Met QC Criteria: February 11, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: SOR469308CTIL