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

This study has been completed.
Sponsor:
Information provided by:
Texas Health Resources
ClinicalTrials.gov Identifier:
NCT00708383
First received: June 29, 2008
Last updated: July 1, 2008
Last verified: June 2008
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Texas Health Resources:

Primary Outcome Measures:
  • Live birth [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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
Experimental: 1
Embryo culture medium supplemented with 0.5% HSA and 10% SSS
Other: 10% SSS embryo culture medium protein supplementation
10% SSS in addition to the 0.5% HSA already in the culture medium.
Active Comparator: 2
Embryo culture medium supplemented with 0.5% HSA only
Other: 0.5% HSA embryo culture medium protein supplementation
0.5% HSA in the culture medium

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00708383

Locations
United States, Texas
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
Presbyterian Hospital of Plano
Plano, Texas, United States, 75093
Sponsors and Collaborators
Texas Health Resources
Investigators
Principal Investigator: Marius Meintjes, PhD Texas Health Resources
  More Information

No publications provided by Texas Health Resources

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marius Meintjes, Presbyterian Hospital of Dallas
ClinicalTrials.gov Identifier: NCT00708383     History of Changes
Other Study ID Numbers: PresbyterianHDallasARTS-SSS
Study First Received: June 29, 2008
Last Updated: July 1, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Health Resources:
embryo development
embryo quality
implantation
IVF/ICSI outcome
multiple pregnancy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014