Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00593775
Enrollment
647
Registered
2008-01-15
Start date
2006-02-28
Completion date
2008-07-31
Last updated
2017-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta; Implantation

Keywords

implantation rate

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.

Interventions

assisted hatching with laser

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 47 Years
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.

Design outcomes

Primary

MeasureTime frame
clinical implantation rate per embryo transferredat 6-8 weeks of pregnancy

Secondary

MeasureTime frame
pregnancy rate per transferat 14-16 days after ovulation or 17 days after the start of progesterone supplementation in a hormone replacement freeze-thaw cycle

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026