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NCT02003157 Clinical Trial

Efficacy of Hypnosis During Embryo Transfer Procedure on Clinical Pregnancy Rate for Patients Undergoing Assisted Reproductive Technology IVF or ICSI

Infertility Clinical Trial

— HYPNOART  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02003157
Other study ID # 2011 A00081-40
Secondary ID
Status Completed
Phase N/A
First received December 1, 2013
Last updated January 14, 2016
Start date June 2011
Est. completion date May 2014

Study information
Verified date October 2011
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical benefits that can be expected by the Embryo transfert procedure with hypnosis to the usual embryo transfer procedure

Recruitment information / eligibility
Status Completed
Enrollment 460
Est. completion date May 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 41 Years
Eligibility Inclusion Criteria:

Consent to participate in study Age = 18 years and < 41 years IVF or IVF/ICSI attempt GnRH antagonist or agonist stimulation protocol Scheduled transfer of 1 or 2 embryos

Exclusion Criteria:

Refusal to provide consent refusal hypnosis FSH > 13 mUImL CFA < 8 follicles AMH < 0.5 ngml Patient not covered by the social security system (NHS)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• hypnosis during embryo transfer or usual transfer procedure

Locations
Country Name City State
France CHU angers Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary pregnancy rate sonography between weeks 5 and 7 after embryo transfer Yes
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