Clinical trial NCT00593775: The Effect of Laser Assisted Hatching in Thawing Cycles: a Prospective Randomized Controlled Study
Official title: The Effect of Laser Assisted Hatching in Thawing Cycles: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta; Implantation
Keywords: implantation rate
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 647
Sex: ALL
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: clinical implantation rate per embryo transferred
timeFrame: at 6-8 weeks of pregnancy
Secondary outcomes:
measure: pregnancy rate per transfer
timeFrame: at 14-16 days after ovulation or 17 days after the start of progesterone supplementation in a hormone replacement freeze-thaw cycle
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Leuven University Fertility Center
Study officials:
affiliation: UZ Leuven
name: Thomas M D'Hooghe, MD
role: STUDY_DIRECTOR
References:
citation: 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.