in Vitro Fertilization (IVF) Media Protein and Live Birth Rates
Completed · Not applicable
Conditions studied: Infertility, Pregnancy Outcome, Live Birth, In Vitro Fertilization
In brief
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.
Key facts
- Study ID
- NCT00708383
- Run by
- Texas Health Resources
- People needed
- 538
- Starts
- 2001-09-01
- Expected to finish
- 2003-11-01
- Last updated by the study team
- 2008-07-02
Who can join
Age: 20 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- First IVF or any donor oocyte cycle
- The eggs may be fertilized with conventional IVF methodology or by using intracytoplasmic sperm injection (ICSI).
- When performing ICSI, ejaculated sperm must be used
- 40 years of age or younger on the day of egg retrieval
You may not qualify if…
- One or more previous failed IVF cycles
- Use of epididymal or testicular sperm for ICSI
- Older than 40 years of age
Where it is running
- Presbyterian Hospital of Dallas — Dallas, Texas, United States
- Presbyterian Hospital of Plano — Plano, Texas, United States
Full record on ClinicalTrials.gov
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