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

September 1, 2015 updated by: Peter Fancsovits, Ph.D., Semmelweis University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

532

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University First Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients entering in vitro fertilization and embryo transfer treatment

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no oocytes collected

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 4 weeks after the embryo transfer
Number of clinical pregnancies (/No. of embryo transfers)
4 weeks after the embryo transfer
Implantation rate
Time Frame: 4 weeks after embryo transfer
Number of embryos implanted (/number of embryos transferred)
4 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization rate
Time Frame: 18 hours after sperm injection
Number of oocytes fertilized. (only in intracytoplasmic sperm injection cycles)
18 hours after sperm injection
Embryo quality
Time Frame: 36 and 72 hours after fertilization
Number and quality of blastomeres, amount of fragmentation embryo grade
36 and 72 hours after fertilization

Other Outcome Measures

Outcome Measure
Time Frame
Time needed for evaluation of zygotes and embryos
Time Frame: 18, 24, 36 and 72 hours after fertilization
18, 24, 36 and 72 hours after fertilization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Investigators

  • Study Chair: Peter Fancsovits, Ph.D., Semmelweis University First Department of Obstetrics and Gynecology
  • Principal Investigator: Adam Lehner, MSc, Semmelweis University First Department of Obstetrics and Gynecology
  • Principal Investigator: Janos Urbancsek, DSc, Semmelweis University First Department of Obstetrics and Gynecology
  • Principal Investigator: Csaba Pribenszky, Ph.D., University of Veterinary Sciences, Budapest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SemmelweisU-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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