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Trial record 9 of 2244 for:    infertility

Expressive Writing in Male Infertility

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00385346
First received: October 5, 2006
Last updated: June 29, 2010
Last verified: September 2009
  Purpose

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.


Condition Intervention
Infertility, Male
Behavioral: Expressive writing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Expressive Writing as a Therapeutic Intervention in Male Infertility

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Scores on rating scale for perceived stress in infertility [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scores on rating scale for personality dimensions [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Sperm parameters [ Time Frame: 3-12 months ] [ Designated as safety issue: No ]
  • Score on rating scale for coping [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: November 2006
Study Completion Date: February 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 1
Expressive writing
Behavioral: Expressive writing
Patients in the intervention group write on three day for 20 minutes about highly emotional topics In the control group patients write on three days for 20 minutes about topics with relatively low emotional involvement such as diet, time management and sport.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  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: NCT00385346

Locations
Germany
University of Bonn, Department of Psychosomatic Medicine
Bonn, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Study Chair: Reinhard Liedtke, MD University of Bonn, Department of Psychosomatic Medicine
  More Information

Publications:

Responsible Party: Prof. Dr. R. Liedtke, Department of Psychosomatic Medicine and Psychotherapy, University of Bonn
ClinicalTrials.gov Identifier: NCT00385346     History of Changes
Other Study ID Numbers: Lfd.Nr.068/06
Study First Received: October 5, 2006
Last Updated: June 29, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Bonn:
Expressive writing
Male infertility

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

ClinicalTrials.gov processed this record on November 25, 2014