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

Other Complications Associated With Artificial Fertilization Clinical Trial

— GroupCulture  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774006
• Other study ID #: SemmelweisU-001
• Status: Completed
• Phase: N/A
• First received: January 18, 2013
• Last updated: September 1, 2015
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Institutional Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Infertile patients entering in vitro fertilization treatment

• at least 1 oocyte collected

Exclusion Criteria:

• no oocytes collected

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
Hungary	Semmelweis University First Department of Obstetrics and Gynecology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time needed for evaluation of zygotes and embryos		18, 24, 36 and 72 hours after fertilization	No
Primary	Clinical pregnancy rate	Number of clinical pregnancies (/No. of embryo transfers)	4 weeks after the embryo transfer	No
Primary	Implantation rate	Number of embryos implanted (/number of embryos transferred)	4 weeks after embryo transfer	No
Secondary	Fertilization rate	Number of oocytes fertilized. (only in intracytoplasmic sperm injection cycles)	18 hours after sperm injection	No
Secondary	Embryo quality	Number and quality of blastomeres, amount of fragmentation embryo grade	36 and 72 hours after fertilization	No