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in Vitro Fertilization (IVF) Media Protein and Live Birth Rates

NCT00708383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2008-07-02

No results posted yet for this 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.

Conditions

  • Infertility
  • Pregnancy Outcome, Live Birth
  • In Vitro Fertilization

Interventions

OTHER

10% SSS embryo culture medium protein supplementation

10% SSS in addition to the 0.5% HSA already in the culture medium.

OTHER

0.5% HSA embryo culture medium protein supplementation

0.5% HSA in the culture medium

Sponsors & Collaborators

  • Texas Health Resources

    lead OTHER

Principal Investigators

  • Marius Meintjes, PhD · Texas Health Resources

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2002-11-30
Completion
2003-11-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00708383 on ClinicalTrials.gov