Salivary Diagnostic Testing for IVF

Completed

• Conditions: Infertility

• Registration Number: NCT02040545
• Lead Sponsor: Boston IVF

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2010-05-21
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Primary Completion: 2016-05
• Status Verified: 2017-04
• Study Completion: 2017-04-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 335

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Equivalence of Salivary Steroid Monitoring to Blood Based Monitoring	1 month	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.

Trial Locations

Locations (6)

HRC Fertility; 🇺🇸 Pasadena, California, United States

Reproductive Biology Associates; 🇺🇸 Atlanta, Georgia, United States

Shady Grove Fertility Reproductive Science Center; 🇺🇸 Rockville, Maryland, United States

Fertility Center of Illinois; 🇺🇸 Chicago, Illinois, United States

Reproductive Medicine Associates of New York, LLP; 🇺🇸 New York, New York, United States

Boston IVF; 🇺🇸 Waltham, Massachusetts, United States