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Impact of Human Embryo Culture System on Live Birth (AGRUPADO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904006
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
IVI Sevilla

Tracking Information
First Submitted Date  ICMJE July 17, 2013
First Posted Date  ICMJE July 19, 2013
Last Update Posted Date April 25, 2018
Actual Study Start Date  ICMJE July 23, 2013
Actual Primary Completion Date November 17, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
Clinical pregnancy rate [ Time Frame: April 2013 - October 2016 ]
Confirmed when a gestational sac with heartbeat was observed in the uterus by ultrasound examination, performed 2-3 weeks after the positive result of the beta-hCG pregnancy test.
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
Clinical pregnancy rate [ Time Frame: June 2013 - August 2014 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
  • Implantation rate [ Time Frame: April 2013 - October 2016 ]
    Number of embryos implanted per number of embryos transferred
  • Live birth rate [ Time Frame: April 2013 - October 2016 ]
    Number of newborns per pregnancy achieved
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
  • Implantation rate [ Time Frame: June 2013 - Ausgust 2014 ]
  • Biochemical pregnancy rate [ Time Frame: June 2013 - Ausgust 2014 ]
  • Embryo quality [ Time Frame: June 2013 - Ausgust 2014 ]
    According to ASEBIR criteria (grades A-D)
Current Other Pre-specified Outcome Measures
 (submitted: November 6, 2017)
  • Fecundation rate [ Time Frame: April 2013 - October 2016 ]
  • Mean number of viable embryos [ Time Frame: April 2013 - October 2016 ]
  • Blastocyst rate [ Time Frame: April 2013 - October 2016 ]
  • Mean number of embryos transferred [ Time Frame: April 2013 - October 2016 ]
  • Live Birth rate per embryos transferred [ Time Frame: April 2013 - October 2016 ]
  • Multiple pregnancy rate [ Time Frame: April 2013 - October 2016 ]
  • Clinical miscarriage rate [ Time Frame: April 2013 - October 2016 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Human Embryo Culture System on Live Birth
Official Title  ICMJE Improvement of Live Birth Rate With a New Standardized Human Embryo Culture System: a Prospective, Randomized, Controlled Trial
Brief Summary

Previous studies in human and different mammals have proved that the embryo group culture (in the same culture medium drop) using a reduced volume is associated with a better embryo development. This is due to the effect of different autocrine and paracrine factors secreted by the embryos. Besides, previous studies with embryos from human and other mammals have shown that a high oxygen concentration may have a negative effect on embryo quality due to the generation of reactive oxygen species, which cause oxidative stress. The embryo culture at low oxygen tension is correlated to better success rates in IVF/ICSI treatments.

The purpose of this study is to evaluate the combined effect of the embryo group culture and the low oxygen tension on the embryo development and the results of the IVF/ICSI treatments. The specific goal is to compare the embryo group culture in a reduced volume of medium at a low oxygen tension (5%) with the standard individual culture at an atmospheric oxygen tension (20%). The first culture condition will be applied in a K-MINC incubator (COOK Medical®), whereas the second condition will be applied using a Heracell incubator (Heraeus®).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Embryo Culture
Intervention  ICMJE
  • Procedure: New Culture Condition
    Intervention group embryos cultured grouped (5 embryos per drop) under low oxygen tension (5%) in benchtop incubators.
  • Procedure: Standard Culture Condition
    Control group embryos cultured individually (1 embryo per drop) under atmospheric oxygen tension (20%) in large-box incubators.
Study Arms  ICMJE
  • Experimental: New Culture Condition
    Intervention group embryos cultured grouped under low oxygen tension in benchtop incubators.
    Intervention: Procedure: New Culture Condition
  • Active Comparator: Standard Culture Condition
    Control group embryos cultured individually under atmospheric oxygen tension in large-box incubators.
    Intervention: Procedure: Standard Culture Condition
Publications * Ruíz M, Santamaría-López E, Blasco V, Hernáez MJ, Caligara C, Pellicer A, Fernández-Sánchez M, Prados N. Effect of Group Embryo Culture under Low-Oxygen Tension in Benchtop Incubators on Human Embryo Culture: Prospective, Randomized, Controlled Trial. Reprod Sci. 2020 Jul;27(7):1522-1533. doi: 10.1007/s43032-020-00150-5. Epub 2020 Jan 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2013)
182
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date November 17, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • <38 years (with own oocytes) / <45 years (with oocyte donation).
  • First treatment with own oocytes / any treatment with oocyte donation.
  • ≥10 oocytes with a diameter of ≥10 mm.

Exclusion Criteria:

  • Diseases that affect endometrial receptivity: endometriosis, hydrosalpinx, ovarian hyperstimulation syndrome, obesity, endocrinopathies, thrombophilia, congenital or acquired uterine anomalies.
  • Patients under a treatment with genetic preimplantation diagnosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01904006
Other Study ID Numbers  ICMJE IVISEV-003AGR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party IVI Sevilla
Study Sponsor  ICMJE IVI Sevilla
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Myriam Ruiz, MSc IVI Sevilla
Study Chair: Victor Blasco, MSc IVI Sevilla
Study Director: Manuel Fernandez-Sánchez, PhD IVI Sevilla
PRS Account IVI Sevilla
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP