NCT00708383

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
538

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2001

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
Last Updated

July 2, 2008

Status Verified

June 1, 2008

Enrollment Period

1.2 years

First QC Date

June 29, 2008

Last Update Submit

July 1, 2008

Conditions

InfertilityPregnancy Outcome, Live BirthIn Vitro Fertilization

Keywords

embryo developmentembryo qualityimplantationIVF/ICSI outcomemultiple pregnancy

Outcome Measures

Primary Outcomes (1)

  • Live birth

    9 months

Secondary Outcomes (1)

  • Implantation rate

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

Embryo culture medium supplemented with 0.5% HSA and 10% SSS

Other: 10% SSS embryo culture medium protein supplementation

2

ACTIVE COMPARATOR

Embryo culture medium supplemented with 0.5% HSA only

Other: 0.5% HSA embryo culture medium protein supplementation

Interventions

10% SSS embryo culture medium protein supplementationOTHER

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

1
0.5% HSA embryo culture medium protein supplementationOTHER

0.5% HSA in the culture medium

2

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

Presbyterian Hospital of Plano

Plano, Texas, 75093, United States

Location

Related Publications (1)

  • Meintjes M, Chantilis SJ, Ward DC, Douglas JD, Rodriguez AJ, Guerami AR, Bookout DM, Barnett BD, Madden JD. 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. Hum Reprod. 2009 Apr;24(4):782-9. doi: 10.1093/humrep/den396. Epub 2009 Jan 14.

    PMID: 19147504DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Marius Meintjes, PhD

    Texas Health Resources

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2008

First Posted

July 2, 2008

Study Start

September 1, 2001

Primary Completion

November 1, 2002

Study Completion

November 1, 2003

Last Updated

July 2, 2008

Record last verified: 2008-06

Locations

US(2)