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

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

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.

Study Overview

• Status: Completed
• Conditions: ART
• Intervention / Treatment: Other: Embryo handling in a closed station

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41011
    • IVI Sevilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IVI Sevilla

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: November 10, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Group embryo culture; Low oxygen tension; Closed station; Embryo handling
• Other Study ID Numbers: 1605-SEV-036-NP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No