InfertilityPhase 1NCT00812890
Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision
A Phase 1 study testing semi-quantitative pregnancy test in people with Infertility, run by Stanford University at 3 sites in United States.
Trial summary
This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- semi-quantitative pregnancy test
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2008to Sep 2009
- Phase
- Phase 1
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women 18 years or older, presenting for early abortion, pre-natal care, or fertility services.
- If pregnant, gestational age < 84 days by LMP, ultrasound or clinical assessment.
- Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
- Able to consent to study participation.
Who cannot join
- Women less than 18 years of age.
- Women who are not pregnant, except if presenting for IVF services.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Family Planning Associates Medical
Chicago, Illinois
Planned Parenthood Mar Monte
Sacromento, California
Stanford University School of Medicine
Stanford, California, 94305
About this study
This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to:
- Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
- Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
- Assess user comprehension of the pregnancy test, especially assessment of the result.
Read the detailed description
This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to:
- Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
- Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
- Assess user comprehension of the pregnancy test, especially assessment of the result.
- Conditions
- Infertility
- Being tested
- semi-quantitative pregnancy test
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-quantitative pregnancy testDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the correlation between this pregnancy test's results with serum values (as distinct from urine) hCG. 2. To assess whether or not urine concentration has any impact on the outcome
Measured: 15 minutes pregnancy test reading
Secondary outcomes (1)
To assess user comprehension of the test.
Measured: study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2009
- Study completionSep 2009
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Gynuity Health Projects
- Investigators
- Dr Paul D Blumenthal, Principal investigator, Stanford UniversityRichard Fischer, Sub-investigator, Planned Parenthood Mar MonteSteve Lichtenberg, Sub-investigator, Family Planning Associates Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812890
- Sponsor's protocol ID
- SU-11042008-1333
- Other IDs
- 14922
- Status last verified
- Jul 2011
- First submitted
- 18 Dec 2008
- Last updated
- 22 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision
- ClinicalTrials.gov ID
- NCT00812890
- Acronym / sponsor ID
- SU-11042008-1333
- Conditions
- Infertility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Gynuity Health Projects
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Dec 2008 (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 will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to:
- Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
- Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
- Assess user comprehension of the pregnancy test, especially assessment of the result.
Detailed description
This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to:
- Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
- Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
- Assess user comprehension of the pregnancy test, especially assessment of the result.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women 18 years or older, presenting for early abortion, pre-natal care, or fertility services.
- If pregnant, gestational age < 84 days by LMP, ultrasound or clinical assessment.
- Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
- Able to consent to study participation.
Key exclusion criteria (2 listed)
- Women less than 18 years of age.
- Women who are not pregnant, except if presenting for IVF services.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semi-quantitative pregnancy test | Device | – |
Primary outcome
To assess the correlation between this pregnancy test's results with serum values (as distinct from urine) hCG. 2. To assess whether or not urine concentration has any impact on the outcome
Time frame: 15 minutes pregnancy test reading
1 secondary outcome
To assess user comprehension of the test.
Time frame: study duration
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 22 Jul 2011.
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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.
Dr Paul D Blumenthal principal investigator
Stanford University
Richard Fischer sub-investigator
Planned Parenthood Mar Monte
Steve Lichtenberg sub-investigator
Family Planning Associates Medical
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing semi-quantitative pregnancy test in people with Infertility, run by Stanford University at 3 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 4 inclusion and 2 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 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To assess the correlation between this pregnancy test's results with serum values (as distinct from urine) hCG. 2. To assess whether or not urine concentration has any impact on the outcome (time frame: 15 minutes pregnancy test reading). 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 22 Jul 2011.