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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003157
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief 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

Condition or disease Intervention/treatment Phase
Infertility Procedure: hypnosis during embryo transfer or usual transfer procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Active Comparator: hypnosis
embryo transfer procedure with hypnosis
Procedure: hypnosis during embryo transfer or usual transfer procedure
Active Comparator: usual
embryo transfer usual procedure
Procedure: hypnosis during embryo transfer or usual transfer procedure



Primary Outcome Measures :
  1. pregnancy rate [ Time Frame: between weeks 5 and 7 after embryo transfer ]
    sonography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003157


Locations
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France
CHU angers
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02003157    
Other Study ID Numbers: 2011 A00081-40
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: October 2011
Keywords provided by University Hospital, Angers:
hypnosis embryo transfer IVF ICSI
Additional relevant MeSH terms:
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Infertility