Application of Two Different Synthetic Sequential Media for the Human IVF-Embryo Transfer (IVF-ET) Program
| Tracking Information | |||||
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| First Received Date ICMJE | May 17, 2011 | ||||
| Last Updated Date | May 18, 2011 | ||||
| Start Date ICMJE | November 2009 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Embryo Quality [ Time Frame: 3 Days ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01356238 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Pregnancy and Implantation rates [ Time Frame: 2 months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Application of Two Different Synthetic Sequential Media for the Human IVF-Embryo Transfer (IVF-ET) Program | ||||
| Official Title ICMJE | Application of Two Different Synthetic Sequential Media for the Human IVF-ET Program | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Infertility | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 360 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 20 Years to 39 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01356238 | ||||
| Other Study ID Numbers ICMJE | MRC-1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jeong Yoon, Maria Fertility Hospital | ||||
| Study Sponsor ICMJE | Maria Fertility Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Maria Fertility Hospital | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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