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

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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

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


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

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Study Type : Observational
Actual Enrollment : 532 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments
Study Start Date : September 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2015

Group/Cohort Intervention/treatment
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




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

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


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

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


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


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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

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
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Hungary
Semmelweis University First Department of Obstetrics and Gynecology
Budapest, Hungary, 1088
Sponsors and Collaborators
Semmelweis University
Investigators
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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

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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 Posted: January 23, 2013    Key Record Dates
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