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

Placenta; Implantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593775
• Other study ID #: ML3497
• Secondary ID: ML3497
• Status: Completed
• Phase: N/A
• First received: January 4, 2008
• Last updated: April 28, 2017
• Start date: February 2006
• Est. completion date: July 2008

Study information

• Verified date: April 2017
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 647
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 47 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta; Implantation

Intervention

Procedure:
• assisted hatching
assisted hatching with laser

Locations

Country	Name	City	State
Belgium	Leuven University Fertility Center	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical implantation rate per embryo transferred		at 6-8 weeks of pregnancy
Secondary	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