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Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization (IVF)

This study has suspended participant recruitment.
(consent form is being revised)
Sponsor:
Information provided by (Responsible Party):
Lisa Kolp, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00788619
First received: November 10, 2008
Last updated: November 1, 2011
Last verified: November 2011
History of Changes

November 10, 2008
November 1, 2011
January 2009
January 2012   (final data collection date for primary outcome measure)
Percentage of subjects with viable pregnancy one month after embryo transfer [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00788619 on ClinicalTrials.gov Archive Site
Percentage of subjects with > 2 viable embryos one month after embryo transfer [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization (IVF)
Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization

Improvements in In-Vitro Fertilization (IVF) outcomes have largely been due to the generation of excess embryos allowing for multiple embryo transfer. Unfortunately this has also increased the risk of multiple pregnancy with associated maternal and neonatal morbidity and mortality. The investigators believe that the concentration of nitric oxide metabolites measured in the culture medium from the first day of culture can identify the best quality embryos allowing us to transfer a limited number of embryos without compromising the optimum chance for pregnancy.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
  • Procedure: Transfer of embryos on day 3 or day 5 after fertilization.
    Subjects will be allocated at random to the two arms. Group 1 will have two embryos transferred on day 3 based on nitric oxide concentration. Group 2 will have two embryos transferred on day 5 based on morphologic criteria.
  • Procedure: Day 5 transfer
    Subjects will have embryo transfer on day 5 after fertilization. Selection of embryos to transfer will be based on morphologic criteria.
  • Active Comparator: Day 3 transfer
    Subjects in this arm will have two embryos transferred three days after fertilization. Embryos will be selected based on the concentration of nitric oxide metabolites in the culture medium.
    Intervention: Procedure: Transfer of embryos on day 3 or day 5 after fertilization.
  • Active Comparator: Day 5 transfer
    Subjects will have two embryos transferred on day 5 after fertilization with selection of embryos based on morphologic criteria.
    Intervention: Procedure: Day 5 transfer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
250
March 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 21-37
  • Female
  • Less than two previous unsuccessful IVF cycles

Exclusion Criteria:

  • Day 3 FSH >9.9
  • Fewer than 8 mature oocytes retrieved
  • Fewer than 8 normally fertilized embryos on day 2 after fertilization
Female
21 Years to 37 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00788619
NA_00013752
No
Lisa Kolp, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Lisa A Kolp, M.D. Johns Hopkins University
Johns Hopkins University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP