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OpenTrials
Completed

NCT Number: NCT03343938

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

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.

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Key information

Conditions

ART

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IVI Sevilla

Seville, 41011, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Embryo handling in a closed station

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vida Recoletas Sevilla

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2017
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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