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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Cryo Innovation
Information provided by (Responsible Party):
Peter Fancsovits, Ph.D., Semmelweis University
ClinicalTrials.gov Identifier:
NCT01774006
First received: January 18, 2013
Last updated: June 6, 2013
Last verified: June 2013
  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 Semmelweis University:

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

  • Implantation rate [ Time Frame: 4 weeks after embryo transfer ] [ Designated as safety issue: No ]
    Number of embryos implanted (/number of embryos transferred)


Secondary Outcome Measures:
  • Fertilization rate [ Time Frame: 18 hours after sperm injection ] [ Designated as safety issue: No ]
    Number of oocytes fertilized. (only in intracytoplasmic sperm injection cycles)

  • Embryo quality [ Time Frame: 36 and 72 hours after fertilization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774006

Locations
Hungary
Semmelweis University First Department of Obstetrics and Gynecology
Budapest, Hungary, 1088
Sponsors and Collaborators
Semmelweis University
Cryo Innovation
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. Cryo Innovation
Principal Investigator: Adam Lehner, MSc Semmelweis University First Department of Obstetrics and Gynecology
  More Information

No publications provided

Responsible Party: Peter Fancsovits, Ph.D., Senior Clinical Embryologyst, Semmelweis University
ClinicalTrials.gov Identifier: NCT01774006     History of Changes
Other Study ID Numbers: SemmelweisU-001
Study First Received: January 18, 2013
Last Updated: June 6, 2013
Health Authority: Hungary: Institutional Ethics Committee

Keywords provided by Semmelweis University:
In vitro fertilization
Embryo transfer
Embryo culture
individual culture
Group culture
embryo quality
Pregnancy rate
Implantation

ClinicalTrials.gov processed this record on August 27, 2014