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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
  Purpose

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.


Condition Intervention Phase
Infertility
 Procedure: Transfer of embryos on day 3 or day 5 after fertilization.
Procedure: Day 5 transfer
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Percentage of subjects with viable pregnancy one month after embryo transfer [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with > 2 viable embryos one month after embryo transfer [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
Active Comparator: Day 5 transfer
Subjects will have two embryos transferred on day 5 after fertilization with selection of embryos 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.

  Eligibility

Ages Eligible for Study:   21 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788619

Locations
United States, Maryland
Johns Hopkins Fertility Center
Lutherville, Maryland, United States, 21093
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Lisa A Kolp, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Lisa Kolp, Assistant Professor of Gynecology and Obstetrics, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00788619     History of Changes
Other Study ID Numbers: NA_00013752
Study First Received: November 10, 2008
Last Updated: November 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Infertility
Assisted reproductive technology
Nitric oxide

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
 Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013