Salivary Diagnostic Testing for IVF

NCT ID: NCT02040545

Last Updated: 2017-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-21

Study Completion Date

2017-04-04

Brief Summary

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

Detailed Description

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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.

Conditions

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Infertility

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Infertility

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boston IVF

OTHER

Sponsor Role lead

Responsible Party

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Alison Zimon

Reproductive Endocrinologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alison Zimon, MD

Role: PRINCIPAL_INVESTIGATOR

Boston IVF

Locations

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HRC Fertility

Pasadena, California, United States

Site Status

Reproductive Biology Associates

Atlanta, Georgia, United States

Site Status

Fertility Center of Illinois

Chicago, Illinois, United States

Site Status

Boston IVF

South Portland, Maine, United States

Site Status

Shady Grove Fertility Reproductive Science Center

Rockville, Maryland, United States

Site Status

Boston IVF

Quincy, Massachusetts, United States

Site Status

Boston IVF

Waltham, Massachusetts, United States

Site Status

Reproductive Medicine Associates of New York, LLP

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20092198

Identifier Type: -

Identifier Source: org_study_id

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