NCT01356238

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
Last Updated

May 19, 2011

Status Verified

October 1, 2009

Enrollment Period

10 months

First QC Date

May 17, 2011

Last Update Submit

May 18, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Embryo Quality

    3 Days

Secondary Outcomes (1)

  • Pregnancy and Implantation rates

    2 months

Study Arms (2)

MRC media

EXPERIMENTAL

Use MRC media in the human IVF-ET program

Other: MRC media

Sydney IVF media

ACTIVE COMPARATOR

Use Sydney IVF media in the human IVF-ET program

Other: Sydney IVF media

Interventions

Culture media

MRC media

Culture media

Sydney IVF media

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing IVF treatment in our clinic during study period

You may not qualify if:

  • Females older than 40 years
  • Patients showed fertilization failure
  • Patients with less than two 2PN embryos

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Fertility Hospital

Seoul, 130-812, South Korea

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Jeong Yoon, M.S.

    Maria Fertility Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 19, 2011

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

May 19, 2011

Record last verified: 2009-10

Locations