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Salivary Diagnostic Testing for IVF

Sponsor
Boston IVF (Other)
Overall Status
Completed
CT.gov ID
NCT02040545
Collaborator
(none)
335
Enrollment
8
Locations
82.5
Actual Duration (Months)
41.9
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    335 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Venopuncture-Free IVF: Can "Patient-friendly" Salivary Hormone Measurements Replace Serum Monitoring of IVF Patients?
    Actual Study Start Date :
    May 21, 2010
    Actual Primary Completion Date :
    May 1, 2016
    Actual Study Completion Date :
    Apr 4, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Infertility

    Patients undergoing ovulation induction and controlled ovarian hyperstimulation at a participating infertility center

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HRC Fertility Pasadena California United States 91105
    2 Reproductive Biology Associates Atlanta Georgia United States 30342
    3 Fertility Center of Illinois Chicago Illinois United States 60610
    4 Boston IVF South Portland Maine United States 04106
    5 Shady Grove Fertility Reproductive Science Center Rockville Maryland United States 20850
    6 Boston IVF Quincy Massachusetts United States 02169
    7 Boston IVF Waltham Massachusetts United States 02451
    8 Reproductive Medicine Associates of New York, LLP New York New York United States 10022

    Sponsors and Collaborators

    • Boston IVF

    Investigators

    • Principal Investigator: Alison Zimon, MD, Boston IVF

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alison Zimon, Reproductive Endocrinologist, Boston IVF
    ClinicalTrials.gov Identifier:
    NCT02040545
    Other Study ID Numbers:
    • 20092198
    First Posted:
    Jan 20, 2014
    Last Update Posted:
    Apr 14, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Alison Zimon, Reproductive Endocrinologist, Boston IVF
    Infertility
    In Vitro Fertilization (IVF)
    Venopuncture-free treatment
    Needle-free treatment
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Apr 14, 2017