An interventional study of assisted hatching in Placenta; Implantation, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 47 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-02.
Sponsored by KU Leuven · Not applicable, Interventional, and Basic science
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).
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.
KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
control group without intervention
assisted hatching performed on the embryo
Procedure: assisted hatching
assisted hatching with laser
clinical implantation rate per embryo transferred
Time frame: at 6-8 weeks of pregnancy
pregnancy rate per transfer
Time frame: at 14-16 days after ovulation or 17 days after the start of progesterone supplementation in a hormone replacement freeze-thaw cycle
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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KU Leuven