Clinical Hypnosis During Insemination or Embryotransfer
This study is currently recruiting participants.
Verified March 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Johann Wolfgang Goethe University Hospitals
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
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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
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 May 16, 2013