Infertility Clinical Trial
— SSSOfficial title:
A Randomized Controlled Study of Human Serum Albumin and Serum Substitute Supplement as Protein Supplements for IVF Culture and the Effect on Live Birth Rates
Verified date | June 2008 |
Source | Texas Health Resources |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 538 |
Est. completion date | November 2003 |
Est. primary completion date | November 2002 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - One or more previous failed IVF cycles - Use of epididymal or testicular sperm for ICSI - Older than 40 years of age |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Presbyterian Hospital of Dallas | Dallas | Texas |
United States | Presbyterian Hospital of Plano | Plano | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Health Resources |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Live birth | 9 months | No | |
Secondary | Implantation rate | 6 weeks | No |
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