Salivary Diagnostic Testing for IVF

Infertility Clinical Trial

Official title:

Venopuncture-Free IVF: Can "Patient-friendly" Salivary Hormone Measurements Replace Serum Monitoring of IVF Patients?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040545
• Other study ID #: 20092198
• Status: Completed
• Phase: N/A
• First received: May 21, 2013
• Last updated: April 13, 2017
• Start date: May 21, 2010
• Est. completion date: April 4, 2017

Study information

• Verified date: April 2017
• Source: Boston IVF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to determine the performance of a salivary hormone competitive immunoassay for monitoring patients during treatment for infertility.

Description:

The goal of this study is to determine the performance of a salivary hormone competitive immunoassay for monitoring patient estrogen and progesterone levels during treatment for infertility using controlled ovarian stimulation (COH) and in vitro fertilization (IVF). Specifically, inter- and intra-assay precision, correlation with serum measurements (the gold-standard), and user satisfaction will be determined. Ultimately, the potential applicability and reliability of salivary steroid monitoring in IVF cycles will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: April 4, 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
United States	Reproductive Biology Associates	Atlanta	Georgia
United States	Fertility Center of Illinois	Chicago	Illinois
United States	Reproductive Medicine Associates of New York, LLP	New York	New York
United States	HRC Fertility	Pasadena	California
United States	Boston IVF	Quincy	Massachusetts
United States	Shady Grove Fertility Reproductive Science Center	Rockville	Maryland
United States	Boston IVF	South Portland	Maine
United States	Boston IVF	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston IVF

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equivalence of Salivary Steroid Monitoring to Blood Based Monitoring	The potential applicability and reliability of salivary steroid monitoring during infertility treatment will be measured as a progression during a patient's IVF stimulation cycle. Concurrent saliva and blood draw measurements of Estradiol and Progesterone will be taken between 3-5 times during a 2-week monitoring period. Equivalence will be determined by the matched progression of Estradiol and progesterone levels (pg/ml) in the same patient at the concurrent times. Saliva Estradiol and Progesterone levels are of a magnitude of 100-200 less than serum based values and are converted using an algorithm to adjust to serum equivalence. Matched T-test will be used to test the hypothesis that the two methods are not statistically different.	1 month