Clinical Hypnosis During Insemination or Embryotransfer

March 30, 2012 updated by: PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospital

Prospective Off-center Randomised Trial of Clinical Hypnosis Versus Relaxation Music

Does clinical hypnosis or relaxation music improve the pregnancy rate if reproduction techniques are required?

Study Overview

Status

Unknown

Study Type

Interventional

Enrollment (Anticipated)

282

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 Contact

  • Name: Joscha Reinhard, Priv.-Doz. Dr. med. MBBS BSc
  • Phone Number: +49-(0)-157 76400061
  • Email: Joscha.Reinhard@kgu.de

Study Locations

    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Recruiting
        • Klinik fur Frauenheilkunde und Geburtshilfe
        • Contact:
          • Joscha Reinhard, Priv.-Doz. Dr. med. MBBS BSc
          • Phone Number: +49-(0)-157 76400061
          • Email: Joscha.Reinhard@kgu.de
        • Principal Investigator:
          • Joscha Reinhard, Priv-Doz Dr. med. MBBS BSc

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Planned insemination or embryo transfer

Exclusion Criteria:

under age not able to understand German

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Relaxation music
25 minute tape recording
Experimental: Clinical hypnosis
25 minute tape recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 4 weeks after insemination / embryotransfer
Outpatient follow up after insemination / embryotransfer for 4 weeks
4 weeks after insemination / embryotransfer

Secondary Outcome Measures

Outcome Measure
Time Frame
Questionnaire: Intervention rating
Time Frame: 5 minutes before and 5 minutes after insemination / embryotransfer
5 minutes before and 5 minutes after insemination / embryotransfer

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Joscha Reinhard, Priv-Doz. Dr. med. MBBS BSc, Goethe University

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

March 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Estimate)

April 2, 2012

Last Update Submitted That Met QC Criteria

March 30, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

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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