Back to resultsEfficacy of Hypnosis During Embryo Transfer Procedure on Clinical Pregnancy Rate for Patients Undergoing Assisted Reproductive Technology IVF or ICSI (HYPNOART)
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hypnosis during embryo transfer or usual transfer procedure
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring hypnosis embryo transfer IVF ICSI
Eligibility 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)
Sites / Locations
- CHU angers
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
hypnosis
usual
Arm Description
embryo transfer procedure with hypnosis
embryo transfer usual procedure
Outcomes
Primary Outcome Measures
pregnancy rate
sonography
Secondary Outcome Measures
Full Information
NCT ID
NCT02003157
First Posted
December 1, 2013
Last Updated
January 14, 2016
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02003157
Brief Title
Efficacy of Hypnosis During Embryo Transfer Procedure on Clinical Pregnancy Rate for Patients Undergoing Assisted Reproductive Technology IVF or ICSI
Acronym
HYPNOART
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
hypnosis embryo transfer IVF ICSI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypnosis
Arm Type
Active Comparator
Arm Description
embryo transfer procedure with hypnosis
Arm Title
usual
Arm Type
Active Comparator
Arm Description
embryo transfer usual procedure
Intervention Type
Procedure
Intervention Name(s)
hypnosis during embryo transfer or usual transfer procedure
Primary Outcome Measure Information:
Title
pregnancy rate
Description
sonography
Time Frame
between weeks 5 and 7 after embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
CHU angers
City
Angers
ZIP/Postal Code
49933
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Hypnosis During Embryo Transfer Procedure on Clinical Pregnancy Rate for Patients Undergoing Assisted Reproductive Technology IVF or ICSI
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