- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01567241
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
Conditions
Intervention / Treatment
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
Keywords
Other Study ID Numbers
- 329/11
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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