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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00788619
• Other study ID #: NA_00013752
• Status: Terminated
• Phase: N/A
• First received: November 10, 2008
• Last updated: December 7, 2017
• Start date: January 2009
• Est. completion date: October 2009

Study information

• Verified date: December 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Fertility Center	Lutherville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with viable pregnancy one month after embryo transfer		1 month
Secondary	Percentage of subjects with > 2 viable embryos one month after embryo transfer		1 month