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OpenTrials
Completed

NCT Number: NCT02040545

Salivary Diagnostic Testing for IVF

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

HRC Fertility, Pasadena, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Equivalence of Salivary Steroid Monitoring to Blood Based Monitoring

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston IVF

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Jan 20, 2014
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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