Evaluation of a Closed Assisted Reproductive Technology (ART) Station Versus an Open Flow Cabinet

Study Overview
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Brief Summary
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There is not yet a standardized system of human embryonic culture in vitro. In addition, technical improvements continually appear. The investigators recently carried out a study in which it shows that the grouped embryo culture at low oxygen tension (5% O2) in a benchtop incubator shows better success rates than individual culture at atmospheric oxygen tension (20% O2) in a conventional incubator. For these reasons, the investigators have decided to continue this research line to evaluate the efficacy of a new ART station with a closed environment in comparison of an open flow cabinet. This new system keeps a controled environment maintaining a carbon dioxide (CO2) concentration of 6% and a temperature of 37 degrees. A prospective randomized study will be carried out in which the manipulation of the gametes and pre-embryos of the patients will be carried out in open laminar flow cabinets or in a closed station that maintain the CO2 and temperature conditions.

Official Title
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Comparative Study Between Two Systems of Gamete and Embryo Handling: Closed Environment Versus Open System

Conditions
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ART

Intervention / Treatment
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* Other: Embryo handling in a closed station


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signing a written consent to participate in the study. Blastocyst transfer: Patients using their own oocytes under 40 years. Patients using donated oocytes. Exclusion Criteria: Preimplantation genetic screening patients. Severe male factor (spermatozoa of testicular or epididymal origin, patients with cryptozoospermia and patients with retrograde ejaculation)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed Station<br>Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees. | Other: Embryo handling in a closed station<br>* Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees.<br>|
| No Intervention: Open flow cabinet<br>Embryo handling is performed inside a conventional open flow cabinet without a controlled environment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo quality | Rate of viable embryos = Transferred and Frozen embryos / Total number of embryos obtained | Through study completion, an average of two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate per first embryo transfer | Total number of live births over the total of recruited patients (taking into account only the first cycle) | Through study completion, an average of two years | 
| Cumulative live birth rate | Total number of live births over the total of recruited patients (taking into account fresh and cryopreserved cycles) | Through study completion, an average of two years | 
| Implantation rate | Total of implanted embryos / total of transferred embryos | Through study completion, an average of two years | 
| Live birth rate of the first cycle per transferred embryo | Total number of live births over the total of transferred embryo | Through study completion, an average of two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group embryo culture, Low oxygen tension, Closed station, Embryo handling