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NCT00708383 · ClinicalTrials.gov registry record · NA
in Vitro Fertilization (IVF) Media Protein and Live Birth Rates
A NA study, sponsored by Texas Health Resources.
- Completed
- Registry status
- NA
- Development phase
- 538
- Enrollment target
NCT00708383 is a NA study that has completed, run by Texas Health Resources. The registered enrollment target is 538 participants.
The verdict
NCT00708383, a NA study, has completed, sponsored by Texas Health Resources.
- COMPLETED
- Registry status
- NA
- Development phase
- 538 participants
- Enrollment target
Study Summary
Human conception in vivo occurs in a complex milieu that includes proteins. It has been speculated that the addition of proteins more complex than human serum albumin to culture media may improve IVF outcomes. Whether the expense, labor and risk of adding additional human-derived protein to IVF media are warranted is a question unanswered. Patients, undergoing routine IVF or ICSI, will be assigned to one of two treatment groups in a randomized, prospective clinical trial . Embryos will be cultured in either media supplemented with human serum albumin (HSA) as a solitary protein supplement or in media supplemented with HSA + SSS from the 2-PN stage until the time of embryo transfer. Clinical endpoints monitored will be implantation rate, clinical pregnancy rate and live birth rate. It is expected that the supplementation of commercial embryo culture media containing HSA with the more complex protein source, SSS, will result in an overall increase in implantation, clinical pregnancy, and live birth rates. In the balance, protein enrichment of media may represent opportunities to simultaneously increase the live birth rate and reduce the incidence of multiple gestations.
Interventions
- OTHER 10% SSS embryo culture medium protein supplementation
- OTHER 0.5% HSA embryo culture medium protein supplementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 538 participants |
| Start Date | 2001-09 |
| Est. Completion | 2003-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00708383
The ClinicalTrials.gov registry entry for NCT00708383 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 538 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas Health Resources, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 10% SSS embryo culture medium protein supplementation is the first listed.
NCT00708383 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00708383 about?
NCT00708383 is a clinical study titled "in Vitro Fertilization (IVF) Media Protein and Live Birth Rates". Human conception in vivo occurs in a complex milieu that includes proteins. It has been speculated that the addition of proteins more complex than human serum albumin to culture media may improve IVF outcomes. Whether the expense, labor and risk of adding additional human-derived protein to IVF medi...
What is the current status of trial NCT00708383?
This trial is currently completed. It is a NA study. The enrollment target is 538 participants. The study started on 2001-09. Estimated completion is 2003-11.
What interventions are being tested in trial NCT00708383?
The interventions under investigation include: 10% SSS embryo culture medium protein supplementation (OTHER), 0.5% HSA embryo culture medium protein supplementation (OTHER).
Who is sponsoring clinical trial NCT00708383?
This trial is sponsored by Texas Health Resources, which has 5 total clinical trials registered on ClinicalTrials.gov.
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