NCT02003157

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 15, 2016

Status Verified

October 1, 2011

Enrollment Period

2.5 years

First QC Date

December 1, 2013

Last Update Submit

January 14, 2016

Conditions

Infertility

Keywords

hypnosis embryo transfer IVF ICSI

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    sonography

    between weeks 5 and 7 after embryo transfer

Study Arms (2)

hypnosis

ACTIVE COMPARATOR

embryo transfer procedure with hypnosis

Procedure: hypnosis during embryo transfer or usual transfer procedure

usual

ACTIVE COMPARATOR

embryo transfer usual procedure

Procedure: hypnosis during embryo transfer or usual transfer procedure

Interventions

hypnosis during embryo transfer or usual transfer procedurePROCEDURE
hypnosisusual

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU angers

Angers, Angers, 49933, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2013

First Posted

December 6, 2013

Study Start

June 1, 2011

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

January 15, 2016

Record last verified: 2011-10

Locations

FR(1)