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

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00788619

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 II Phase III

MedlinePlus related topics: Infertility

Drug Information available for: Nitric oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization

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 Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Day 3 transfer: Active Comparator 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.
Day 5 transfer: Active Comparator 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

Contacts

Contact: Lisa A Kolp, M.D.

410-583-2750

lkolp@jhmi.edu

Locations

United States, Maryland
Johns Hopkins Fertility Center
Lutherville, Maryland, United States, 21093

Sponsors and Collaborators

Johns Hopkins University

More Information

Responsible Party:	Johns Hopkins School of Medicine ( Lisa Kolp, MD )
Study ID Numbers:	NA_00013752
Study First Received:	November 10, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00788619
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Infertility
Assisted reproductive technology
Nitric oxide

Study placed in the following topic categories:

Nitric Oxide
Genital Diseases, Female
Infertility
Genital Diseases, Male

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents

Protective Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 11, 2009