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

January 14, 2016 updated by: University Hospital, Angers
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

460

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Chu Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: between weeks 5 and 7 after embryo transfer
sonography
between weeks 5 and 7 after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 1, 2013

First Submitted That Met QC Criteria

December 1, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011 A00081-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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