Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome

Study Overview
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Brief Summary
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The objective of study is to assess the possible impact of assisted hatching on the implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human embryos.

Detailed Description
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The embryo implantation rate in assisted reproduction procedures is 20%, which leads to a low clinical pregnancy rate (35%), and even lower live birth rate (25%), per cycle started. Low embryo quality, poor endometrial receptivity, difficulties during the blastocyst hatching process are frequently denoted as the main reasons for the low implantation rate in humans. The artificial rupture or thinning of the zona pellucida before embryo transfer-assisted hatching (AH)-has been proposed to foster spontaneous hatching and improve embryo implantation rates. Despite great effort, the clinical relevance of AH remains controversial and elusive. There is a great importance of AH during frozen embryo cycles. Due to previous studies there is no precise answer about the value of AH performed on cryopreserved-thawed embryos. As far as is known, there is no clinical data to indicate the effects of AH on vitrified-warmed embryo transfer. The objective of this prospective study is to assess the possible impact of assisted hatching on the implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human embryos. Eligibility criteria: women age 18-42, cleavage-stage embryo transfer, less than seven IVF cycles with fresh embryo transfer, high quality embryos. Procedure: mechanical Assisted Hatching Primary Outcome: delivery rate Secondary Outcome: implantation rate, pregnancy rate and delivery rate.

Official Title
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Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome

Conditions
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Placenta; Implantation, Complications Associated With Artificial Fertilization, Pregnancy

Intervention / Treatment
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* Device: Mechanical Assisted Hatching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women age 18-42, cleavage-stage embryo transfer, less than seven IVF cycles with fresh embryo transfer, high quality embryos. Exclusion Criteria: out of 18-42 y.o. blastocyst embryo transfer more or equal to seven IVF cycles with fresh embryo transfer low quality embryos

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Assisted Hatching<br>No Assisted Hatching | |
| Active Comparator: Assisted Hatching<br>Mechanical Assisted Hatching - artificial rupture of the embryo external glycoprotein layer (Zona Pellucida) before embryo transfer. | Device: Mechanical Assisted Hatching<br>* The technique of assisted hatching using partial zona pellucida dissection to create an artificial opening of the zona pellucida of early cleaved embryos. While the embryo is stabilized by a holding pipette of micromanipulator, the zona pellucida is pierced with a microneedle that is pushed tangentially through the space between the zona pellucida and blastomeres until it pierces through the zona pellucida again.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delivery rate |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate |  | 1 month | 
| clinical pregnancy rate |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitrification, In Vitro Fertilization, Frozen Embryo, Assisted Hatching, Pregnancy Rate