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| Sponsor: | Texas Health Resources |
|---|---|
| Information provided by: | Texas Health Resources |
| ClinicalTrials.gov Identifier: | NCT00708383 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Infertility Pregnancy Outcome, Live Birth In Vitro Fertilization |
Other: 10% SSS embryo culture medium protein supplementation Other: 0.5% HSA embryo culture medium protein supplementation |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
| Official 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 |
| Enrollment: | 538 |
| Study Start Date: | September 2001 |
| Study Completion Date: | November 2003 |
| Primary Completion Date: | November 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Embryo culture medium supplemented with 0.5% HSA and 10% SSS
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Other: 10% SSS embryo culture medium protein supplementation
10% SSS in addition to the 0.5% HSA already in the culture medium.
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2: Active Comparator
Embryo culture medium supplemented with 0.5% HSA only
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Other: 0.5% HSA embryo culture medium protein supplementation
0.5% HSA in the culture medium
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Show Detailed Description Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Presbyterian Hospital of Dallas | |
| Dallas, Texas, United States, 75231 | |
| Presbyterian Hospital of Plano | |
| Plano, Texas, United States, 75093 | |
| Principal Investigator: | Marius Meintjes, PhD | Texas Health Resources |
More Information
| Responsible Party: | Presbyterian Hospital of Dallas ( Marius Meintjes ) |
| Study ID Numbers: | PresbyterianHDallasARTS-SSS |
| Study First Received: | June 29, 2008 |
| Last Updated: | July 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00708383 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
embryo development embryo quality implantation IVF/ICSI outcome multiple pregnancy |
|
Genital Diseases, Female Infertility Genital Diseases, Male |
