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Clinical Hypnosis During Insemination or Embryotransfer

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ClinicalTrials.gov Identifier: NCT01567241
Recruitment Status : Unknown
Verified March 2012 by PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospitals.
Recruitment status was:  Recruiting
First Posted : March 30, 2012
Last Update Posted : April 2, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Does clinical hypnosis or relaxation music improve the pregnancy rate if reproduction techniques are required?

Condition or disease Intervention/treatment
Reproduction Dysfunction Other: clinical hypnosis or relaxation music

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Prospective Off-center Randomised Trial of Clinical Hypnosis Versus Relaxation Music
Study Start Date : March 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : March 2014
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Relaxation music Other: clinical hypnosis or relaxation music
25 minute tape recording
Experimental: Clinical hypnosis Other: clinical hypnosis or relaxation music
25 minute tape recording


Outcome Measures

Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 4 weeks after insemination / embryotransfer ]
    Outpatient follow up after insemination / embryotransfer for 4 weeks


Secondary Outcome Measures :
  1. Questionnaire: Intervention rating [ Time Frame: 5 minutes before and 5 minutes after insemination / embryotransfer ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Planned insemination or embryo transfer

Exclusion Criteria:

under age not able to understand German

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567241


Contacts
Contact: Joscha Reinhard, Priv.-Doz. Dr. med. MBBS BSc +49-(0)-157 76400061 Joscha.Reinhard@kgu.de

Locations
Germany
Klinik für Frauenheilkunde und Geburtshilfe Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Joscha Reinhard, Priv.-Doz. Dr. med. MBBS BSc    +49-(0)-157 76400061    Joscha.Reinhard@kgu.de   
Principal Investigator: Joscha Reinhard, Priv-Doz Dr. med. MBBS BSc         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Joscha Reinhard, Priv-Doz. Dr. med. MBBS BSc Goethe University
More Information

Responsible Party: PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Principal investigator, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01567241     History of Changes
Other Study ID Numbers: 329/11
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012

Keywords provided by PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospitals:
clinical hypnosis
relaxation music
reproduction techniques
insemination
embryo transfer
pregnancy rate