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Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments (GroupCulture)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774006
First Posted: January 23, 2013
Last Update Posted: September 2, 2015
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.
Information provided by (Responsible Party):
Peter Fancsovits, Ph.D., Semmelweis University
  Purpose

Prospective randomized comparison of two widely used in vitro culture system in human IVF treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media droplets using conventional petridish or in group culture using WOW (well of the well) petridish.

Primary outcome: implantation and pregnancy rates Secondary outcome: fertilization rate and embryo quality


Condition Intervention
Other Complications Associated With Artificial Fertilization Other: individual embryo culture or group culture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments

Further study details as provided by Peter Fancsovits, Ph.D., Semmelweis University:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 4 weeks after the embryo transfer ]
    Number of clinical pregnancies (/No. of embryo transfers)

  • Implantation rate [ Time Frame: 4 weeks after embryo transfer ]
    Number of embryos implanted (/number of embryos transferred)


Secondary Outcome Measures:
  • Fertilization rate [ Time Frame: 18 hours after sperm injection ]
    Number of oocytes fertilized. (only in intracytoplasmic sperm injection cycles)

  • Embryo quality [ Time Frame: 36 and 72 hours after fertilization ]
    Number and quality of blastomeres, amount of fragmentation embryo grade


Other Outcome Measures:
  • Time needed for evaluation of zygotes and embryos [ Time Frame: 18, 24, 36 and 72 hours after fertilization ]

Enrollment: 532
Study Start Date: September 2012
Study Completion Date: September 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group culture
Embryos cultured in groups of 2-10
Other: individual embryo culture or group culture
Embryos cultured in a 25 microliter droplet of culture media individually in a conventional petridish or in groups of 2-10 embryos in a Well-of-the-Well petridish
Individual culture
Embryos cultured individually
Other: individual embryo culture or group culture
Embryos cultured in a 25 microliter droplet of culture media individually in a conventional petridish or in groups of 2-10 embryos in a Well-of-the-Well petridish

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients entering in vitro fertilization and embryo transfer treatment
Criteria

Inclusion Criteria:

  • Infertile patients entering in vitro fertilization treatment
  • at least 1 oocyte collected

Exclusion Criteria:

  • no oocytes collected
  Contacts and Locations
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): NCT01774006


Locations
Hungary
Semmelweis University First Department of Obstetrics and Gynecology
Budapest, Hungary, 1088
Sponsors and Collaborators
Semmelweis University
Investigators
Principal Investigator: Janos Urbancsek, DSc Semmelweis University First Department of Obstetrics and Gynecology
Study Chair: Peter Fancsovits, Ph.D. Semmelweis University First Department of Obstetrics and Gynecology
Principal Investigator: Csaba Pribenszky, Ph.D. University of Veterinary Sciences, Budapest
Principal Investigator: Adam Lehner, MSc Semmelweis University First Department of Obstetrics and Gynecology
  More Information

Responsible Party: Peter Fancsovits, Ph.D., Senior Clinical Embryologyst, Semmelweis University
ClinicalTrials.gov Identifier: NCT01774006     History of Changes
Other Study ID Numbers: SemmelweisU-001
First Submitted: January 18, 2013
First Posted: January 23, 2013
Last Update Posted: September 2, 2015
Last Verified: September 2015

Keywords provided by Peter Fancsovits, Ph.D., Semmelweis University:
In vitro fertilization
Embryo transfer
Embryo culture
individual culture
Group culture
embryo quality
Pregnancy rate
Implantation