Salivary Diagnostic Testing for IVF

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02040545

Enrollment

335

Registered

2014-01-20

Start date

2010-05-21

Completion date

2017-04-04

Last updated

2017-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Infertility, In Vitro Fertilization (IVF), Venopuncture-free treatment, Needle-free treatment

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results