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

NCT ID: NCT00593775

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 647 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-07-31

Brief Summary

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).

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.

Conditions

Placenta; Implantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

control

control group without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

AH group

assisted hatching performed on the embryo

Group Type: ACTIVE_COMPARATOR

assisted hatching

Intervention Type: PROCEDURE

assisted hatching with laser

Interventions

assisted hatching

assisted hatching with laser

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 47 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Sophie Debrock

PhD, clinical embryologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas M D'Hooghe, MD

Role: STUDY_DIRECTOR

UZ Leuven

Locations

Leuven University Fertility Center

Leuven, , Belgium

Countries

Belgium

References

Debrock S, Peeraer K, Spiessens C, Willemen D, De Loecker P, D'Hooghe TM. The effect of modified quarter laser-assisted zona thinning on the implantation rate per embryo in frozen/vitrified-thawed/warmed embryo transfer cycles: a prospective randomized controlled trial. Hum Reprod. 2011 Aug;26(8):1997-2007. doi: 10.1093/humrep/der161. Epub 2011 Jun 8.

Reference Type: DERIVED

PMID: 21659315 (View on PubMed)

Other Identifiers

ML3497

Identifier Type: REGISTRY

Identifier Source: secondary_id

ML3497

Identifier Type: -

Identifier Source: org_study_id