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

This study has been terminated.
(difficulty with recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788619
First Posted: November 11, 2008
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  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
Infertility Procedure: Transfer of embryos on day 3 or day 5 after fertilization. Procedure: Day 5 transfer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • Percentage of subjects with > 2 viable embryos one month after embryo transfer [ Time Frame: 1 month ]

Enrollment: 2
Actual Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 37 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00788619     History of Changes
Other Study ID Numbers: NA_00013752
First Submitted: November 10, 2008
First Posted: November 11, 2008
Last Update Posted: December 11, 2017
Last Verified: December 2017

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
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents