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

ART Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343938
• Other study ID #: 1605-SEV-036-NP
• Status: Completed
• Phase: N/A
• Start date: October 31, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: February 2020
• Source: IVI Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 30, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• ART

Intervention

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

Locations

Country	Name	City	State
Spain	IVI Sevilla	Seville

Sponsors (1)

Lead Sponsor	Collaborator
IVI Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryo quality	Rate of viable embryos = Transferred and Frozen embryos / Total number of embryos obtained	Through study completion, an average of two years
Secondary	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
Secondary	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
Secondary	Implantation rate	Total of implanted embryos / total of transferred embryos	Through study completion, an average of two years
Secondary	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