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

NCT ID: NCT00788619

Last Updated: 2017-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Keywords

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Infertility Assisted reproductive technology Nitric oxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Transfer of embryos on day 3 or day 5 after fertilization.

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

Day 5 transfer

Intervention Type PROCEDURE

Subjects will have embryo transfer on day 5 after fertilization. Selection of embryos to transfer will be based on morphologic criteria.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa A Kolp, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Fertility Center

Lutherville, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00013752

Identifier Type: -

Identifier Source: org_study_id