Artificial Shrinkage of Fresh Blastocysts

Study Overview
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Brief Summary
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The aim of the study is to determine if collapsing an embryo (or making it fold compactly by taking away its fluid) before the transfer in the uterine cavity improves pregnancy rates in assisted reproductive technology (ART). Women coming to our ART center will be randomized in two groups : the collapsing group and a control group. Pregnancy rates will be compared in the two groups. A biomarker (cell free DNA) will also be determined in each group and correlated to pregnancy occurrence.

Detailed Description
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This is a prospective randomized study designed to determine if artificial shrinkage (AS) before transfer of embryos impact clinical pregnancy rate in single blastocyst embryo transfer (SBET) cycle. Women elected for SBET will be randomized on transfer day in two arms:the AS group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer and a control group. Clinical pregnancy rates will be compared. Secondarily, rate of monozygotic twin pregnancy and cell free DNA concentration in culture medium will be evaluated in the two groups.

Official Title
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Artificial Shrinkage of Fresh Blastocyst: Impact on Success Rates in Assisted Reproductive Technology

Conditions
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Infertility Assisted Reproductive Technology

Intervention / Treatment
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* Procedure: Artificial shrinkage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Couple eligible for a transfer of a single embryo at the blastocyst stage Available couple for a follow up of 12 months Exclusion Criteria: Attempt with frozen embryo or frozen oocyte Attempt with a pre-implantation diagnosis Patient has not signed informed consent Couple in a period of exclusion determined by a previous study Couple under legal protection, guardianship or guardianship

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial shrinkage (AS) group<br>The Artificial shrinkage group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer | Procedure: Artificial shrinkage<br>* Artificial shrinkage of blastocyst<br>|
| No Intervention: Control group<br>No intervention on blastocoelic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate embryo transfer | Clinical pregnancy rate by transfer evaluate by the visualization of at least one gestational sac with fetal heart activity during pelvic ultrasound confirmed by a positive result of the quantitative βHCG blood test. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Twin pregnancy rate by transfer | Twin pregnancy rate by transfer evaluate the presence of 2 cardiac activities on ultrasound. | 5 weeks | 
| Free DNA level | Free DNA content contained in the drop of culture medium collected after transfer. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single blastocyst embryo transfer, Artificial Shrinkage, Clinical pregnancy rate, Cell free