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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Katholieke Universiteit Leuven.
Recruitment status was:  Recruiting
Information provided by:
Katholieke Universiteit Leuven Identifier:
First received: January 4, 2008
Last updated: January 14, 2008
Last verified: December 2007

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 ]

Secondary Outcome Measures:
  • pregnancy rate per transfer [ Time Frame: end of study ]

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


Ages Eligible for Study:   18 Years to 47 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00593775

Contact: Sophie G Debrock, PhD 00 32 16 34 08 12

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Thomas D'Hooghe, Leuven University Fertility Center Identifier: NCT00593775     History of Changes
Other Study ID Numbers: ML3497
Study First Received: January 4, 2008
Last Updated: January 14, 2008

Keywords provided by Katholieke Universiteit Leuven:
implantation rate processed this record on April 28, 2017