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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593775
First Posted: January 15, 2008
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sophie Debrock, Katholieke Universiteit Leuven
  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
Placenta; Implantation Procedure: assisted hatching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Sophie Debrock, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • clinical implantation rate per embryo transferred [ Time Frame: at 6-8 weeks of pregnancy ]

Secondary Outcome Measures:
  • pregnancy rate per transfer [ Time Frame: at 14-16 days after ovulation or 17 days after the start of progesterone supplementation in a hormone replacement freeze-thaw cycle ]

Enrollment: 647
Study Start Date: February 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
control group without intervention
Active Comparator: AH group
assisted hatching performed on the embryo
Procedure: assisted hatching
assisted hatching with laser

Detailed Description:
In view of insufficient clinical evidence demonstrating the value of AH at the start of our study and in view of the need for higher implantation and LBRs in our ART programme within a series of reimbursed cycles, a prospective randomized controlled trial was performed to evaluate the effect of AH, by modified quarter laser-assisted zona thinning (mQLAZT), in our cryopreservation program. The primary aim was to test the hypothesis that the IR per embryo transferred is higher after transfer of frozen/vitrified-thawed/warmed embryos with thinned ZP after mQLAZT when compared with the transfer of frozen/vitrified-thawed/warmed embryos without mQLAZT.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 47 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593775


Locations
Belgium
Leuven University Fertility Center
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Study Director: Thomas M D'Hooghe, MD UZ Leuven
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sophie Debrock, PhD, clinical embryologist, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT00593775     History of Changes
Other Study ID Numbers: ML3497
ML3497 ( Registry Identifier: Ethical Committee of our University hospital )
First Submitted: January 4, 2008
First Posted: January 15, 2008
Last Update Posted: May 2, 2017
Last Verified: April 2017

Keywords provided by Sophie Debrock, Katholieke Universiteit Leuven:
implantation rate