Assisted Hatching in Frozen Blastocysts

Study Overview
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Brief Summary
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The current study aims to assess the effect of assisted hatching on the implantation rate of frozen blastocytes.

Detailed Description
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The Zona Pellucida protects the ovum from the penetration of multiple sperm, and from mechanical and physiological damage until the fertilized ovum reaches the uterus. Subsequently, spontaneous hatching occurs, and enables the embryo to attach to the endometrium. The technique of assisted hatching was originally investigated as a means to improve implantation in cases of zona hardening, and is commonly performed in 3-day embryos. In the current study, the investigators aim to investigate the effect of assisted hatching on 5-day frozen embryos.

Official Title
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The Effect of Assisted Hatching on Implantation Rate in Frozen Blastocyst Transfer - a Prospective Randomized Controlled Study

Conditions
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ART

Intervention / Treatment
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* Procedure: Assisted hatching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In-vitro fertilization patients at the investigators' institution, intended to undergo a transfer of a frozen five-day embryo (blastocyte) 18 to 39 years old First to third treatment cycle Patient has previously had a maximum of four embryos transferred. Exclusion Criteria: Over 40 years old Congenital or acquired uterine malformations Hydrosalpinx Chronic autoimmune diseases Embryo intended to be undergo preimplantation genetic diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assisted hatching<br>Five-day frozen embryos will undergo assisted hatching prior to embryo transfer | Procedure: Assisted hatching<br>* Controlled hatching of the zona pellucida in the laboratory prior to embryo transfer<br>|
| No Intervention: Control<br>Five-day frozen embryos will not undergo any additional procedures prior to embryo transfer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | Number of gestational sacs demonstrated on ultrasound divided by the number of embryos transferred (expressed as percentage) | Five to six weeks following embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemical pregnancy | Increase and subsequent decrease in beta HCG levels with no evidence of gestational sac on ultrasound | Five to six weeks following embryo transfer | 
| Early spontaneous abortion | Spontaneous abortion of pregnancy during the first trimester of pregnancy | Up to 15 weeks from embryo transfer |