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

NCT03343938 | Completed

• 1 other identifier: 1605-SEV-036-NP
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Keywords

Group embryo culture; Low oxygen tension; Closed station; Embryo handling

Outcome Measures

Primary Outcomes (1)

• Embryo quality

  Rate of viable embryos = Transferred and Frozen embryos / Total number of embryos obtained

  Through study completion, an average of two years

Secondary Outcomes (4)

• Live birth rate per first embryo transfer

  Through study completion, an average of two years

• Cumulative live birth rate

  Through study completion, an average of two years

• Implantation rate

  Through study completion, an average of two years

• Live birth rate of the first cycle per transferred embryo

  Through study completion, an average of two years

Study Arms (2)

Closed Station

EXPERIMENTAL

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

Other: Embryo handling in a closed station

Open flow cabinet

NO INTERVENTION

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

Interventions

Embryo handling in a closed station OTHER

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

Closed Station

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signing a written consent to participate in the study.
• Blastocyst transfer:
• Patients using their own oocytes under 40 years.
• Patients using donated oocytes.

You may not qualify if:

• Preimplantation genetic screening patients.
• Severe male factor (spermatozoa of testicular or epididymal origin, patients with cryptozoospermia and patients with retrograde ejaculation)

Sponsors & Collaborators

• Vida Recoletas Sevilla: lead

Study Sites (1)

IVI Sevilla

Seville, 41011, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 17, 2017
• Study Start: October 31, 2017
• Primary Completion: October 31, 2019
• Study Completion: November 30, 2019
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)