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

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: NCT01774006
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Peter Fancsovits, Ph.D., Semmelweis University

Tracking Information
First Submitted Date January 18, 2013
First Posted Date January 23, 2013
Last Update Posted Date September 2, 2015
Study Start Date September 2012
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2013)
  • 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)
Original Primary Outcome Measures
 (submitted: January 18, 2013)
Pregnancy rate, implantation rate [ Time Frame: 1 year after the embryo transfer ]
Change History
Current Secondary Outcome Measures
 (submitted: January 18, 2013)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 18, 2013)
Time needed for evaluation of zygotes and embryos [ Time Frame: 18, 24, 36 and 72 hours after fertilization ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments
Official Title Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments
Brief Summary

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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients entering in vitro fertilization and embryo transfer treatment
Condition Other Complications Associated With Artificial Fertilization
Intervention 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
Study Groups/Cohorts
  • Group culture
    Embryos cultured in groups of 2-10
    Intervention: Other: individual embryo culture or group culture
  • Individual culture
    Embryos cultured individually
    Intervention: Other: individual embryo culture or group culture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 1, 2015)
532
Original Estimated Enrollment
 (submitted: January 18, 2013)
400
Actual Study Completion Date September 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no oocytes collected
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT01774006
Other Study ID Numbers SemmelweisU-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Peter Fancsovits, Ph.D., Semmelweis University
Study Sponsor Semmelweis University
Collaborators Not Provided
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
PRS Account Semmelweis University
Verification Date September 2015