Clinical Hypnosis During Insemination or Embryotransfer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01567241
First received: March 22, 2012
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention
Reproduction Dysfunction
Other: clinical hypnosis or relaxation music

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Prospective Off-center Randomised Trial of Clinical Hypnosis Versus Relaxation Music

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 4 weeks after insemination / embryotransfer ] [ Designated as safety issue: No ]
    Outpatient follow up after insemination / embryotransfer for 4 weeks


Secondary Outcome Measures:
  • Questionnaire: Intervention rating [ Time Frame: 5 minutes before and 5 minutes after insemination / embryotransfer ] [ Designated as safety issue: No ]

Estimated Enrollment: 282
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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: 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 Hospitals
Investigators
Principal Investigator: Joscha Reinhard, Priv-Doz. Dr. med. MBBS BSc Goethe University
  More Information

No publications provided

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
Study First Received: March 22, 2012
Last Updated: March 30, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
clinical hypnosis
relaxation music
reproduction techniques
insemination
embryo transfer
pregnancy rate

ClinicalTrials.gov processed this record on July 20, 2014