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

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ClinicalTrials.gov Identifier: NCT03343938
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
IVI Sevilla

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.

Condition or disease Intervention/treatment
ART Other: Embryo handling in a closed station

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Comparative Study Between Two Systems of Gamete and Embryo Handling: Closed Environment Versus Open System
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018

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.



Primary Outcome Measures :
  1. Embryo quality [ Time Frame: Through study completion, an average of two years ]
    Rate of viable embryos = Transferred and Frozen embryos / Total number of embryos obtained


Secondary Outcome Measures :
  1. Live birth rate per first embryo transfer [ Time Frame: Through study completion, an average of two years ]
    Total number of live births over the total of recruited patients (taking into account only the first cycle)

  2. Cumulative live birth rate [ Time Frame: Through study completion, an average of two years ]
    Total number of live births over the total of recruited patients (taking into account fresh and cryopreserved cycles)

  3. Implantation rate [ Time Frame: Through study completion, an average of two years ]
    Total of implanted embryos / total of transferred embryos

  4. Live birth rate of the first cycle per transferred embryo [ Time Frame: Through study completion, an average of two years ]
    Total number of live births over the total of transferred embryo



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343938


Contacts
Contact: Esther Santamaría-López, MSc 954286274 ext 19528 esther.santamaria@ivi.es
Contact: Victor Blasco, MSc 954286274 ext 19523 victor.blasco@ivi.es

Locations
Spain
IVI Sevilla Recruiting
Seville, Spain, 41011
Contact: Esther Santamaría-López, MSc    954286274 ext 19528    esther.santamaria@ivi.es   
Contact: Victor Blasco, MSc    954286274 ext 19523    victor.blasco@ivi.es   
Sponsors and Collaborators
IVI Sevilla

Responsible Party: IVI Sevilla
ClinicalTrials.gov Identifier: NCT03343938     History of Changes
Other Study ID Numbers: 1605-SEV-036-NP
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by IVI Sevilla:
Group embryo culture
Low oxygen tension
Closed station
Embryo handling