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

Primary Purpose

Infertility

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transfer of embryos on day 3 or day 5 after fertilization.
Day 5 transfer
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, Assisted reproductive technology, Nitric oxide

Eligibility Criteria

21 Years - 37 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Fertility Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Day 3 transfer

Day 5 transfer

Arm Description

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.

Subjects will have two embryos transferred on day 5 after fertilization with selection of embryos based on morphologic criteria.

Outcomes

Primary Outcome Measures

Percentage of subjects with viable pregnancy one month after embryo transfer

Secondary Outcome Measures

Percentage of subjects with > 2 viable embryos one month after embryo transfer

Full Information

First Posted
November 10, 2008
Last Updated
December 7, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00788619
Brief Title
Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization (IVF)
Official Title
Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
difficulty with recruitment
Study Start Date
January 2009 (Actual)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Assisted reproductive technology, Nitric oxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Day 3 transfer
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Day 5 transfer
Arm Type
Active Comparator
Arm Description
Subjects will have two embryos transferred on day 5 after fertilization with selection of embryos based on morphologic criteria.
Intervention Type
Procedure
Intervention Name(s)
Transfer of embryos on day 3 or day 5 after fertilization.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Day 5 transfer
Intervention Description
Subjects will have embryo transfer on day 5 after fertilization. Selection of embryos to transfer will be based on morphologic criteria.
Primary Outcome Measure Information:
Title
Percentage of subjects with viable pregnancy one month after embryo transfer
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Percentage of subjects with > 2 viable embryos one month after embryo transfer
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A Kolp, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Fertility Center
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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