Salivary Diagnostic Testing for IVF

N/ACompletedNCT02040545

Boston IVF335 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

335

Conditions

Infertility

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center

Locations (8)

HRC Fertility

Pasadena, California, United States

Reproductive Biology Associates

Atlanta, Georgia, United States

Fertility Center of Illinois

Chicago, Illinois, United States

Boston IVF

South Portland, Maine, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Data from ClinicalTrials.gov

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