Reproduction DysfunctionNCT01567241
Clinical Hypnosis During Insemination or Embryotransfer
A study testing clinical hypnosis or relaxation music in people with Reproduction Dysfunction, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Does clinical hypnosis or relaxation music improve the pregnancy rate if reproduction techniques are required? Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Reproduction Dysfunction
- What is being tested?
- clinical hypnosis or relaxation music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned insemination or embryo transfer
Who cannot join
- under age not able to understand German
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Frauenheilkunde und Geburtshilfe
Frankfurt am Main, Hesse, 60590
Joscha Reinhard, Priv.-Doz. Dr. med. MBBS BSc, +49-(0)-157 76400061, Joscha.Reinhard@kgu.de
Joscha Reinhard, Priv-Doz Dr. med. MBBS BSc
About this study
Official title: 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?
- Conditions
- Reproduction Dysfunction
- Being tested
- clinical hypnosis or relaxation music
- Keywords
- clinical hypnosis, relaxation music, reproduction techniques, insemination, embryo transfer, pregnancy rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical hypnosis or relaxation musicOther
25 minute tape recording
| Study group | Role | What they receive |
|---|---|---|
| Relaxation music | Placebo comparator | Not described Receives: Other: clinical hypnosis or relaxation music |
| Clinical hypnosis | Experimental | Not described Receives: Other: clinical hypnosis or relaxation music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Outpatient follow up after insemination / embryotransfer for 4 weeks
Measured: 4 weeks after insemination / embryotransfer
Secondary outcomes (1)
Questionnaire: Intervention rating
Measured: 5 minutes before and 5 minutes after insemination / embryotransfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproduction DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospital
- Investigators
- Joscha Reinhard, Priv-Doz. Dr. med. MBBS BSc, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567241
- Sponsor's protocol ID
- 329/11
- Status last verified
- Mar 2012
- First submitted
- 22 Mar 2012
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Off-center Randomised Trial of Clinical Hypnosis Versus Relaxation Music
- ClinicalTrials.gov ID
- NCT01567241
- Acronym / sponsor ID
- 329/11
- Conditions
- Reproduction Dysfunction
- Keywords
- clinical hypnosis, relaxation music, reproduction techniques, insemination, embryo transfer, pregnancy rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Does clinical hypnosis or relaxation music improve the pregnancy rate if reproduction techniques are required?
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation music | Placebo comparator | Other: clinical hypnosis or relaxation music |
| Clinical hypnosis | Experimental | Other: clinical hypnosis or relaxation music |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned insemination or embryo transfer
Key exclusion criteria (1 listed)
- under age not able to understand German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical hypnosis or relaxation music25 minute tape recording | Other | Clinical hypnosis, Relaxation music |
Primary outcome
Pregnancy rate
Time frame: 4 weeks after insemination / embryotransfer
Outpatient follow up after insemination / embryotransfer for 4 weeks
1 secondary outcome
Questionnaire: Intervention rating
Time frame: 5 minutes before and 5 minutes after insemination / embryotransfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joscha Reinhard, Priv-Doz. Dr. med. MBBS BSc principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical hypnosis or relaxation music in people with Reproduction Dysfunction, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joscha Reinhard, Priv.-Doz. Dr. med. MBBS BSc (+49-(0)-157 76400061, Joscha.Reinhard@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: 4 weeks after insemination / embryotransfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.