Clinical Hypnosis During Insemination or Embryotransfer | NCT01567241

Studies
Clinical Hypnosis During Insemination or Embryotransfer

NCT01567241

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Unknown status

Last Update Posted

Apr 2, 2012Estimated

Enrollment

282Estimated

Phase

Not Applicable

Conditions

Reproduction Dysfunction

Interventions

clinical hypnosis or relaxation music

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Aug 2013Estimated

Completion Date

Mar 2014Estimated

First Submitted Date

Mar 22, 2012

First Submission Date that Met QC Criteria

Mar 29, 2012

First Posted Date

Mar 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2012

Last Update Posted Date

Apr 2, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Principal investigator, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

282Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Relaxation music	Placebo Comparator		Other: clinical hypnosis or relaxation music
Clinical hypnosis	Experimental		Other: clinical hypnosis or relaxation music

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clinical hypnosis or relaxation music	Other	25 minute tape recording	Clinical hypnosis Relaxation music

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy rate	Outpatient follow up after insemination / embryotransfer for 4 weeks	4 weeks after insemination / embryotransfer

Secondary Outcomes

Measure	Description	Time Frame
Questionnaire: Intervention rating		5 minutes before and 5 minutes after insemination / embryotransfer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Planned insemination or embryo transfer

Exclusion Criteria:

under age not able to understand German

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joscha Reinhard, Priv.-Doz. Dr. med. MBBS BSc	Contact	+49-(0)-157 76400061		Joscha.Reinhard@kgu.de

Overall Officials

Name	Affiliation	Role
Joscha Reinhard, Priv-Doz. Dr. med. MBBS BSc	Goethe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Frauenheilkunde und Geburtshilfe	Recruiting	Frankfurt am Main	Hesse	60590	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D006990	Hypnosis

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D011613	Psychotherapy

Browse Leaves

Not provided

Browse Branches

Not provided