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

NCT00788619 | Terminated

• 1 other identifier: NA_00013752
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Infertility; Assisted reproductive technology; Nitric oxide

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with viable pregnancy one month after embryo transfer

  1 month

Secondary Outcomes (1)

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

  1 month

Study Arms (2)

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.

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

Interventions

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

Day 5 transfer PROCEDURE

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

Day 5 transfer

Eligibility Criteria

• Age: 21 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21-37
• Female
• Less than two previous unsuccessful IVF cycles

You may not qualify if:

• Day 3 FSH \>9.9
• Fewer than 8 mature oocytes retrieved
• Fewer than 8 normally fertilized embryos on day 2 after fertilization

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Fertility Center

Lutherville, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Lisa A Kolp, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 11, 2008
• Study Start: January 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

US (1)