Salivary Diagnostic Testing for IVF
Venopuncture-Free IVF: Can "Patient-friendly" Salivary Hormone Measurements Replace Serum Monitoring of IVF Patients?
1 other identifier
observational
335
1 country
8
Brief Summary
This study aims to determine the performance of a salivary hormone competitive immunoassay for monitoring patients during treatment for infertility.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2010
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2010
CompletedFirst Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
January 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2017
CompletedApril 14, 2017
April 1, 2017
6 years
May 21, 2013
April 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Equivalence of Salivary Steroid Monitoring to Blood Based Monitoring
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
Study Arms (1)
Infertility
Patients undergoing ovulation induction and controlled ovarian hyperstimulation at a participating infertility center
Eligibility Criteria
Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center
You may qualify if:
- Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston IVFlead
Study Sites (8)
HRC Fertility
Pasadena, California, 91105, United States
Reproductive Biology Associates
Atlanta, Georgia, 30342, United States
Fertility Center of Illinois
Chicago, Illinois, 60610, United States
Boston IVF
South Portland, Maine, 04106, United States
Shady Grove Fertility Reproductive Science Center
Rockville, Maryland, 20850, United States
Boston IVF
Quincy, Massachusetts, 02169, United States
Boston IVF
Waltham, Massachusetts, 02451, United States
Reproductive Medicine Associates of New York, LLP
New York, New York, 10022, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alison Zimon, MD
Boston IVF
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Reproductive Endocrinologist
Study Record Dates
First Submitted
May 21, 2013
First Posted
January 20, 2014
Study Start
May 21, 2010
Primary Completion
May 1, 2016
Study Completion
April 4, 2017
Last Updated
April 14, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share