InfertilityNCT02040545
Salivary Diagnostic Testing for IVF
An observational study of Infertility, run by Boston IVF at 8 sites in United States.
Trial summary
This study aims to determine the performance of a salivary hormone competitive immunoassay for monitoring patients during treatment for infertility. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 335 participants
- Where
- 8 sitesUnited States
- Study dates
- 21 May 2010to 4 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center
Who may be able to join
- Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Reproductive Biology Associates
Atlanta, Georgia, 30342
Fertility Center of Illinois
Chicago, Illinois, 60610
Reproductive Medicine Associates of New York, LLP
New York, New York, 10022
HRC Fertility
Pasadena, California, 91105
Boston IVF
Quincy, Massachusetts, 02169
Shady Grove Fertility Reproductive Science Center
Rockville, Maryland, 20850
Boston IVF
South Portland, Maine, 04106
Boston IVF
Waltham, Massachusetts, 02451
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Keywords
- Infertility, In Vitro Fertilization (IVF), Venopuncture-free treatment, Needle-free treatment
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infertility | Patients undergoing ovulation induction and controlled ovarian hyperstimulation at a participating infertility center |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study start21 May 2010
- Primary completionMay 2016
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston IVF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Zimon, Boston IVF
- Investigators
- Alison Zimon, MD, Principal investigator, Boston IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040545
- Sponsor's protocol ID
- 20092198
- Status last verified
- Apr 2017
- First submitted
- 21 May 2013
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venopuncture-Free IVF: Can "Patient-friendly" Salivary Hormone Measurements Replace Serum Monitoring of IVF Patients?
- ClinicalTrials.gov ID
- NCT02040545
- Acronym / sponsor ID
- 20092198
- Conditions
- Infertility
- Keywords
- Infertility, In Vitro Fertilization (IVF), Venopuncture-free treatment, Needle-free treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Boston IVFUniversity, hospital or other
- Study start
- 21 May 2010 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the performance of a salivary hormone competitive immunoassay for monitoring patients during treatment for infertility.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertility | – | –Patients undergoing ovulation induction and controlled ovarian hyperstimulation at a participating infertility center |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center
Key inclusion criteria (1 listed)
- Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Zimon, MD principal investigator
Boston IVF
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Boston IVF at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence of Salivary Steroid Monitoring to Blood Based Monitoring (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.