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

This study has been completed.
Sponsor:
Collaborator:
Ben-Gurion University of the Negev
Information provided by (Responsible Party):
Eitan Lunenfeld, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00685282
First received: May 25, 2008
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Infertility
Stress
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
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.

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • pregnancy [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DNA damage/ γH2AX [ Time Frame: with in IVF cycle (2 months) ] [ Designated as safety issue: No ]
  • decreased stress [ Time Frame: two months ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: November 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685282

Locations
Israel
IVF Clinic Soroka UMC
Beer Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
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
  More Information

No publications provided

Responsible Party: Eitan Lunenfeld, Head of the IVF Unit at the Soroka Medical Center, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00685282     History of Changes
Other Study ID Numbers: SOR469308CTIL
Study First Received: May 25, 2008
Last Updated: February 11, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014