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

December 7, 2017 updated by: Johns Hopkins University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 37 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with viable pregnancy one month after embryo transfer
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with > 2 viable embryos one month after embryo transfer
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Lisa A Kolp, M.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2009

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (ESTIMATE)

November 11, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2017

Last Update Submitted That Met QC Criteria

December 7, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00013752

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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