NCT00561249

Brief Summary

At the time of transfer of frozen/thawed embryos in human IVF/ICSI, patients are randomized between study and control group.In the control group no additional intervention takes place on the embryos to be transferred,in the study group, embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
293

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 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

First Submitted

Initial submission to the registry

November 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

January 27, 2014

Status Verified

January 1, 2014

Enrollment Period

5.3 years

First QC Date

November 16, 2007

Last Update Submit

January 24, 2014

Conditions

IVFICSI

Outcome Measures

Primary Outcomes (1)

  • clinical implantation per transferred embryo

    fourteen days after transfer

Secondary Outcomes (1)

  • clinical pregnancy and birth per transfer

    resp. 12 weeks and 38 weeks after transfer

Study Arms (2)

1

EXPERIMENTAL

Embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo.

Procedure: laser assisted hatching

2

NO INTERVENTION

No intervention

Interventions

laser assisted hatchingPROCEDURE

Embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old and above
  • Female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

Study Officials

  • Petra De Sutter, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 20, 2007

Study Start

December 1, 2007

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 27, 2014

Record last verified: 2014-01

Locations

BE(1)