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

Not Applicable

Completed

• Conditions: ART
• Interventions: Other: Embryo handling in a closed station

• Registration Number: NCT03343938
• Lead Sponsor: IVI Sevilla

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-31
• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-17
• Primary Completion: 2019-10-31
• Study Completion: 2019-11-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Closed Station	Embryo handling in a closed station	Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees.

Primary Outcome Measures

Name	Time	Method
Embryo quality	Through study completion, an average of two years	Rate of viable embryos = Transferred and Frozen embryos / Total number of embryos obtained

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IVI Sevilla; 🇪🇸 Seville, Spain