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Randomized Prospective Trial on the Use of Laser Assisted Hatching (LAH) for Transfer of Frozen/Thawed Embryos in Human IVF/ICSI

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00561249
First received: November 16, 2007
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
IVF
ICSI
 Procedure: laser assisted hatching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Prospective Trial on the Use of Laser Assisted Hatching (LAH) for Transfer of Frozen/Thawed Embryos in Human IVF/ICSI

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • clinical implantation per transferred embryo [ Time Frame: fourteen days after transfer ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical pregnancy and birth per transfer [ Time Frame: resp. 12 weeks and 38 weeks after transfer ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 660
Study Start Date: December 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo
No Intervention: 2
No intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old and above
  • Female

Exclusion Criteria:

  • No exclusion criteria, except not possible to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561249

Contacts
Contact: Ilse De Croo, MSc 0032/(0)9/332.31.71 ilse.decroo@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Ilse De Croo, MSc     0032/(0)9/332.31.71     ilse.decroo@ugent.be    
Principal Investigator: Petra De Sutter, MD, PhD            
Sub-Investigator: Ilse De Croo, MSc            
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Petra De Sutter, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00561249     History of Changes
Other Study ID Numbers: 2007/453
Study First Received: November 16, 2007
Last Updated: January 29, 2013
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013