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

NCT ID: NCT03343938

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2019-11-30

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.

Conditions

ART

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Closed Station

Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees.

Group Type: EXPERIMENTAL

Embryo handling in a closed station

Intervention Type: OTHER

Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees.

Open flow cabinet

Embryo handling is performed inside a conventional open flow cabinet without a controlled environment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Embryo handling in a closed station

Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vida Recoletas Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IVI Sevilla

Seville, , Spain

Countries

Spain

Other Identifiers

1605-SEV-036-NP

Identifier Type: -

Identifier Source: org_study_id