Salivary Diagnostic Testing for IVF

April 13, 2017 updated by: Alison Zimon, Boston IVF

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

335

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • HRC Fertility
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Reproductive Biology Associates
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Fertility Center of Illinois
    • Maine
      • South Portland, Maine, United States, 04106
        • Boston IVF
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Shady Grove Fertility Reproductive Science Center
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • Boston IVF
      • Waltham, Massachusetts, United States, 02451
        • Boston IVF
    • New York
      • New York, New York, United States, 10022
        • Reproductive Medicine Associates of New York, LLP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Infertility
Patients undergoing ovulation induction and controlled ovarian hyperstimulation at a participating infertility center

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston IVF

Investigators

  • Principal Investigator: Alison Zimon, MD, Boston IVF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2010

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

April 4, 2017

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20092198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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