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Clinical Trials/NCT00385346
NCT00385346
Completed
Not Applicable

Expressive Writing as a Therapeutic Intervention in Male Infertility

University Hospital, Bonn1 site in 1 country56 target enrollmentNovember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility, Male
Sponsor
University Hospital, Bonn
Enrollment
56
Locations
1
Primary Endpoint
Scores on rating scale for perceived stress in infertility
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

The purpose of this study is to determine whether expressive writing can be effective in improving the well-being and sperm quality in patients with male infertility.

Detailed Description

Expressive writing is a therapeutic intervention designed by the psychologist James W. Pennebaker. Individuals write on three days for about 20 minutes about particularly stressful experiences in their life. Several studies showed that expressive writing can have beneficial effects on the frequency of health care utilization and well-being. Particularly in patients with rheumatism, kidney cancer and posttraumatic stress disorder expressive writing showed an positive effect on subjective well-being. Furthermore, in several studies expressive writing showed a positive effect on immune parameters. As many studies suggest an important negative effect of stress on well-being and sperm parameters in male infertility, we want to investigate the effect of expressive writing in male infertility.The expressive writing condition is compared to a non emotional writing condition, in which individuals write about mainly non emotional topics such as time management. In this randomized-controlled trial subjects were allocated sequentially by block wise randomization (block size of 4). For randomization a computer generated random list was used. The allocation was concealed in a series of numbered sealed envelopes. The envelope was opened immediately before the first writing session.

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
February 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
University Hospital, Bonn

Eligibility Criteria

Inclusion Criteria

  • Male infertile patients with a pathological spermiogram according to WHO criteria

Exclusion Criteria

  • Drugs affecting sperm quality
  • Patients with chromosomal anomalies affecting sperm quality (e.g. Klinefelter- Syndrome)
  • Severe Psychiatric disorder defined as psychotic disorder (schizophrenia, bipolar disorder) or substance-related disorder
  • Patients currently in psychotherapeutic or psychiatric therapy

Outcomes

Primary Outcomes

Scores on rating scale for perceived stress in infertility

Time Frame: 3 months

Secondary Outcomes

  • Sperm parameters(3-12 months)
  • Scores on rating scale for personality dimensions(3 months)
  • Score on rating scale for coping(3 months)

Study Sites (1)

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