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

I

IVI Sevilla

Status

Completed

Conditions

ART

Treatments

Other: Embryo handling in a closed station

Study type

Interventional

Funder types

Other

Identifiers

NCT03343938
1605-SEV-036-NP

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

All

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

78 participants in 2 patient groups

Closed Station
Experimental group
Description:
Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees.
Treatment:
Other: Embryo handling in a closed station
Open flow cabinet
No Intervention group
Description:
Embryo handling is performed inside a conventional open flow cabinet without a controlled environment.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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