Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments (GroupCulture)
This study is currently recruiting participants.
Verified January 2013 by Semmelweis University
Sponsor:
Semmelweis University
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: January 22, 2013
Last verified: January 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774006
Contacts
| Contact: Peter Fancsovits, Ph.D. | +36208250520 | fancsovits.peter@noi1.sote.hu |
| Contact: Janos Urbancsek, DSc | +3612660115 | urbancsek.janos@noi1.sote.hu |
Locations
| Hungary | |
| Semmelweis University First Department of Obstetrics and Gynecology | Recruiting |
| Budapest, Hungary, 1088 | |
| Contact: Peter Fancsovits, Ph.D. | |
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: | January 22, 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 May 16, 2013