Expressive Writing in Male Infertility

June 29, 2010 updated by: University Hospital, Bonn

Expressive Writing as a Therapeutic Intervention in Male Infertility

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • University of Bonn, Department of Psychosomatic Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scores on rating scale for perceived stress in infertility
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Scores on rating scale for personality dimensions
Time Frame: 3 months
3 months
Sperm parameters
Time Frame: 3-12 months
3-12 months
Score on rating scale for coping
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Study Chair: Reinhard Liedtke, MD, University of Bonn, Department of Psychosomatic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 5, 2006

First Submitted That Met QC Criteria

October 5, 2006

First Posted (Estimate)

October 9, 2006

Study Record Updates

Last Update Posted (Estimate)

June 30, 2010

Last Update Submitted That Met QC Criteria

June 29, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lfd.Nr.068/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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