The Effect of Laser Assisted Hatching in Thawing Cycles: a Prospective Randomized Controlled Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Katholieke Universiteit Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00593775
First received: January 4, 2008
Last updated: January 14, 2008
Last verified: December 2007
  Purpose

The successful hatching process is a prerequisite for implantation. Freezing/thawing cycles can impair the hatching process by introducing changes in the composition of the zona pellucida. The purpose of this study is to test the hypothesis that the implantation rate per embryo and the clinical pregnancy rate per embryo transfer is higher after embryo transfer of frozen-thawed embryos with opened or thinned ZP after assisted hatching when compared to embryo transfer of frozen-thawed embryos without assisted hatching.

All patients starting a thawing cycle (with frozen embryos on d1-d2-d3-d5) can be included in this RTC study. Assisted hatching will be performed with a non-contact 1.48 diode laser system (MTG, Germany).


Condition Intervention
Embryo Implantation
Procedure: assisted hatching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Laser Assisted Hatching in Thawing Cycles: a Prospective Randomized Controlled Study

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • clinical implantation rate per embryo transferred [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pregnancy rate per transfer [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: February 2006
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
Active Comparator: AH group
assisted hatching performed on the embryo
Procedure: assisted hatching
assisted hatching with laser

  Eligibility

Ages Eligible for Study:   18 Years to 47 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients with frozen 2pn, embryos and blastocysts who want to start an embryo thawing cycle can be included in this study.

Exclusion Criteria:

  • Patients participating in the embryo reception program are excluded.
  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: NCT00593775

Contacts
Contact: Sophie G Debrock, PhD 00 32 16 34 08 12 sophie.debrock@uzleuven.be

Locations
Belgium
Leuven University Fertility Center Recruiting
Leuven, Belgium, 3000
Contact: Sophie G Debrock, PhD    00 32 16 34 08 12    Sophie.debrock@uzleuven.be   
Principal Investigator: sophie G Debrock, PhD         
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Study Director: Thomas M D'Hooghe, MD UZ Leuven
  More Information

No publications provided by Katholieke Universiteit Leuven

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas D'Hooghe, Leuven University Fertility Center
ClinicalTrials.gov Identifier: NCT00593775     History of Changes
Other Study ID Numbers: ML3497, ML3497
Study First Received: January 4, 2008
Last Updated: January 14, 2008
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Katholieke Universiteit Leuven:
implantation rate

ClinicalTrials.gov processed this record on October 19, 2014