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

Infertility Clinical Trial

Official title:

Application of Two Different Synthetic Sequential Media for the Human IVF-ET Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356238
• Other study ID #: MRC-1
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: May 18, 2011
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2009
• Source: Maria Fertility Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• MRC media
Culture media
• Sydney IVF media
Culture media

Locations

Country	Name	City	State
Korea, Republic of	Maria Fertility Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Maria Fertility Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryo Quality		3 Days	Yes
Secondary	Pregnancy and Implantation rates		2 months	Yes