Application of Two Different Synthetic Sequential Media for the Human IVF-Embryo Transfer (IVF-ET) Program

This study has been completed.
Sponsor:
Information provided by:
Maria Fertility Hospital
ClinicalTrials.gov Identifier:
NCT01356238
First received: May 17, 2011
Last updated: May 18, 2011
Last verified: October 2009
  Purpose

Quality-controlled commercial media have been used in many in-vitro fertilization (IVF) laboratories. However, commercial media are costly and difficult to compare directly because their exact compositions are not clearly indicated. Although commercially available media have commonly been used in most IVF programs worldwide, there are several advantages to the use of in-house synthetic sequential media at IVF laboratories. First, the results of quality control should be reliable due to a stringent protocol setting-up. Second, any direct supplementations or deletions of specific components are feasible to obtain good quality embryos and high pregnancy rates since those components can be defined. Finally, dependence on commercially available media diminishes so that the laboratory can more easily accommodate unexpected situations or problems, such as a sudden increase in IVF patients. Therefore, the present study was conducted to compare the efficacy of in-house MRC media in the human IVF-embryo transfer (ET) program to that of commercially available media.


Condition Intervention
Infertility
Other: MRC media
Other: Sydney IVF media

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Application of Two Different Synthetic Sequential Media for the Human IVF-ET Program

Resource links provided by NLM:


Further study details as provided by Maria Fertility Hospital:

Primary Outcome Measures:
  • Embryo Quality [ Time Frame: 3 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pregnancy and Implantation rates [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 360
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRC media
Use MRC media in the human IVF-ET program
Other: MRC media
Culture media
Active Comparator: Sydney IVF media
Use Sydney IVF media in the human IVF-ET program
Other: Sydney IVF media
Culture media

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing IVF treatment in our clinic during study period

Exclusion Criteria:

  • Females older than 40 years
  • Patients showed fertilization failure
  • Patients with less than two 2PN embryos
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356238

Locations
Korea, Republic of
Maria Fertility Hospital
Seoul, Korea, Republic of, 130-812
Sponsors and Collaborators
Maria Fertility Hospital
Investigators
Principal Investigator: Jeong Yoon, M.S. Maria Fertility Hospital
  More Information

No publications provided

Responsible Party: Jeong Yoon, Maria Fertility Hospital
ClinicalTrials.gov Identifier: NCT01356238     History of Changes
Other Study ID Numbers: MRC-1
Study First Received: May 17, 2011
Last Updated: May 18, 2011
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 14, 2014