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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00561249
First received: November 16, 2007
Last updated: January 24, 2014
Last verified: January 2014
  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 ]

Enrollment: 293
Study Start Date: December 2007
Study Completion Date: April 2013
Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561249

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Petra De Sutter, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
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 24, 2014
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014