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

Not Applicable

Completed

• Conditions: Placenta; Implantation
• Interventions: Procedure: assisted hatching

• Registration Number: NCT00593775
• Lead Sponsor: KU Leuven

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 647

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AH group	assisted hatching	assisted hatching performed on the embryo

Primary Outcome Measures

Name	Time	Method
clinical implantation rate per embryo transferred	at 6-8 weeks of pregnancy

Secondary Outcome Measures

Name	Time	Method
pregnancy rate per transfer	at 14-16 days after ovulation or 17 days after the start of progesterone supplementation in a hormone replacement freeze-thaw cycle

Trial Locations

Locations (1)

Leuven University Fertility Center; 🇧🇪 Leuven, Belgium