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
| Tracking Information | |||||
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| First Received Date ICMJE | March 22, 2012 | ||||
| Last Updated Date | March 30, 2012 | ||||
| Start Date ICMJE | March 2012 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pregnancy rate [ Time Frame: 4 weeks after insemination / embryotransfer ] [ Designated as safety issue: No ] Outpatient follow up after insemination / embryotransfer for 4 weeks |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01567241 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Questionnaire: Intervention rating [ Time Frame: 5 minutes before and 5 minutes after insemination / embryotransfer ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Hypnosis During Insemination or Embryotransfer | ||||
| Official Title ICMJE | Prospective Off-center Randomised Trial of Clinical Hypnosis Versus Relaxation Music | ||||
| Brief Summary | Does clinical hypnosis or relaxation music improve the pregnancy rate if reproduction techniques are required? |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
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| Condition ICMJE | Reproduction Dysfunction | ||||
| Intervention ICMJE | Other: clinical hypnosis or relaxation music
25 minute tape recording |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 282 | ||||
| Estimated Completion Date | March 2014 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Planned insemination or embryo transfer Exclusion Criteria: under age not able to understand German |
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01567241 | ||||
| Other Study ID Numbers ICMJE | 329/11 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospitals | ||||
| Study Sponsor ICMJE | Johann Wolfgang Goethe University Hospitals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Johann Wolfgang Goethe University Hospitals | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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