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

NCT01774006 | Completed

• 1 other identifier: SemmelweisU-001
• Study Type: observational
• Target: 532
• Locations: 1 country
• Sites: 1

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

Conditions

Other Complications Associated With Artificial Fertilization

Keywords

In vitro fertilization; Embryo transfer; Embryo culture; individual culture; Group culture; embryo quality; Pregnancy rate; Implantation

Outcome Measures

Primary Outcomes (2)

• Clinical pregnancy rate

  Number of clinical pregnancies (/No. of embryo transfers)

  4 weeks after the embryo transfer

• Implantation rate

  Number of embryos implanted (/number of embryos transferred)

  4 weeks after embryo transfer

Secondary Outcomes (2)

• Fertilization rate

  18 hours after sperm injection

• Embryo quality

  36 and 72 hours after fertilization

Other Outcomes (1)

• Time needed for evaluation of zygotes and embryos

  18, 24, 36 and 72 hours after fertilization

Study Arms (2)

Group culture

Embryos cultured in groups of 2-10

Other: individual embryo culture or group culture

Individual culture

Embryos cultured individually

Other: individual embryo culture or group culture

Interventions

individual embryo culture or group culture OTHER

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

Group culture; Individual culture

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients entering in vitro fertilization and embryo transfer treatment

You may qualify if:

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

You may not qualify if:

• no oocytes collected

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University First Department of Obstetrics and Gynecology

Budapest, 1088, Hungary

Location

Related Publications (1)

• Fancsovits P, Pribenszky C, Lehner A, Murber A, Kaszas Z, Nemes A, Urbancsek J. Prospective-randomized study comparing clinical outcomes of IVF treatments where embryos were cultured individually or in a microwell group culture dish. Biol Futur. 2022 Jun;73(2):229-236. doi: 10.1007/s42977-022-00113-8. Epub 2022 Mar 12.

  PMID: 35278201 DERIVED

Study Officials

• Janos Urbancsek, DSc

  Semmelweis University First Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Peter Fancsovits, Ph.D.

  Semmelweis University First Department of Obstetrics and Gynecology

  STUDY CHAIR

• Csaba Pribenszky, Ph.D.

  University of Veterinary Sciences, Budapest

  PRINCIPAL INVESTIGATOR

• Adam Lehner, MSc

  Semmelweis University First Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Embryologyst

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 23, 2013
• Study Start: September 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

HU (1)