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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Placenta; Implantation

Intervention / Treatment
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* Procedure: assisted hatching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>control group without intervention | |
| Active Comparator: AH group<br>assisted hatching performed on the embryo | Procedure: assisted hatching<br>* assisted hatching with laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical implantation rate per embryo transferred |  | at 6-8 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implantation rate