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Completed

NCT Number: NCT00685282

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

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.

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Key information

Conditions

Infertility Genital Diseases Stress Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVF Clinic Soroka UMC

Beersheba, 84101, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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 outcomes

  1. pregnancy

    Time frame: two years

Secondary outcomes

  1. DNA damage/ γH2AX

    Time frame: with in IVF cycle (2 months)

  2. decreased stress

    Time frame: two months

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Collaborators

  • Ben-Gurion University of the Negev

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 28, 2008
Registry last updated
Feb 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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