Embryo TransferNCT01919502
Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
A study testing Semi-quantitative urine pregnancy test in people with Embryo Transfer and Intrauterine Insemination (IUI), run by Gynuity Health Projects at 1 site in United States.
Trial summary
Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, the investigators would like to document the feasibility and acceptability of a semi-quantitative pregnancy test as an adjunct to or replacement of current monitoring protocols to offer women and health care providers a new… 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
- Embryo Transfer, Intrauterine Insemination (IUI)
- What is being tested?
- Semi-quantitative urine pregnancy test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Apr 2014
- Phase
- Interventional
- 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
- Planning embryo transfer or intrauterine insemination (IUI)
- Agrees to return for a series of follow-up visits
- Willing to follow provider instructions regarding use of at-home pregnancy test
- Has not already participated in this study (each woman can only participate once)
- Able to read and write in English
- Willing to provide an address and/or telephone number to be contacted for purposes of follow-up
- Willing and able to consent to study participation
Who cannot join
- Does not agree to return for a series of follow-up visits
- Not willing to follow provider instructions regarding use of at-home pregnancy test
- Has already participated in this study (each woman can only participate once)
- Not able to read and write in English
- Not willing to provide an address and/or telephone number to be contacted for purposes of follow-up
- Not willing and able to consent to study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Palo Alto, California, 94305
About this study
Official title: Feasibility and Acceptability of Using a Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, the investigators would like to document the feasibility and acceptability of a semi-quantitative pregnancy test as an adjunct to or replacement of current monitoring protocols to offer women and health care providers a new choice of diagnostic tools to confirm early pregnancy. The pilot will help us to better understand how this tool complements existing monitoring protocols. If a suitable addition or replacement to repeat blood draws for serum hCG assessment, the SQPT could also contribute to efforts to make assisted fertility treatments more patient-friendly. This study seeks to test this innovation by asking women assigned to perform a Quanti5 Multilevel hCG Pregnancy Test (Athenium Pharmaceuticals, LLC, Nashville, TN) at home on a weekly basis for up to 4 weeks after egg retrieval/embryo transfer or intrauterine insemination.
The investigators hypothesize that the test, which can be used at home by women, will provide confirmation of the presence of a pregnancy compared with standard serum hCG testing because 1) it has sensitivity and specificity that correlates well with serum testing, and 2) it can be used at home and thus earlier to determine presence of hCG.
- Conditions
- Embryo Transfer, Intrauterine Insemination (IUI)
- Being tested
- Semi-quantitative urine pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-quantitative urine pregnancy testDevice
Also called Quanti5 Multilevel hCG Pregnancy Test
| Study group | Role | What they receive |
|---|---|---|
| Semi-quantitative urine pregnancy test | Other | Semi-quantitative urine pregnancy test (Quanti5 Multilevel hCG Pregnancy Test) Receives: Device: Semi-quantitative urine pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of SQPT results that accurately monitor pregnancy
Participants will have follow-up visits that include serum hCG testing and ultrasounds to confirm pregnancy. Will be able to compare these results to the results of the at-home pregnancy test.
Measured: 6 weeks
Secondary outcomes (3)
Feasibility of women using this test at home
Feasibility of women using this test at home on their own as a potential future substitute or complement to standard sequential clinic-based visits to monitor pregnancy after embryo transfer or IUI. Forms given to document their results at home will include questions on feasibility. Exit interview will also include questions regarding feasibility.
Measured: 6 weeks
Acceptability of semi-quantitative pregnancy test
Acceptability of using semi-quantitative pregnancy at home instead of tests standard clinic-based monitoring after embryo transfer or IUI. Forms given to document their results at home will include questions on acceptability. Exit interview will also include questions regarding acceptability.
Measured: 6 weeks
Effectiveness of written instructions and provider's counseling
Assess if written instructions and provider's counseling enable women using the semi-quantitative pregnancy test at home to understand how it should be used and to correctly interpret the test result. Forms given to document their results at home will include questions on whether the oral and written instructions helped interpret the results. Exit interview will be conducted to determine how the additional information made the participant feel about conducting the test (i.e. more relaxed, less relaxed, or no difference).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Embryo TransferStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Lynn Westphal, MD, Principal investigator, Division of Reproductive Endocrinology and Infertility Stanford University School of MedicinePaul Blumenthal, MD, MPH, Principal investigator, Dept of Obstetrics and Gynecology, Stanford University, Stanford University School of MedicineWendy Sheldon, MPH, MSW, PhD, Principal investigator, Gynuity Health ProjectsBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919502
- Sponsor's protocol ID
- 6004
- Status last verified
- May 2014
- First submitted
- 5 Aug 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shochet T, Comstock IA, Ngoc NTN, Westphal LM, Sheldon WR, Loc LT, Blum J, Winikoff B, Blumenthal PD. Results of a pilot study in the U.S. and Vietnam to assess the utility and acceptability of a multi-level pregnancy test (MLPT) for home monitoring of hCG trends after assisted reproduction. BMC Womens Health. 2017 Aug 22;17(1):67. doi: 10.1186/s12905-017-0422-y.
PubMed 28830483
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Using a Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
- ClinicalTrials.gov ID
- NCT01919502
- Acronym / sponsor ID
- 6004
- Conditions
- Embryo Transfer, Intrauterine Insemination (IUI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Aug 2013 (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.
Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, the investigators would like to document the feasibility and acceptability of a semi-quantitative pregnancy test as an adjunct to or replacement of current monitoring protocols to offer women and health care providers a new choice of diagnostic tools to confirm early pregnancy. The pilot will help us to better understand how this tool complements existing monitoring protocols. If a suitable addition or replacement to repeat blood draws for serum hCG assessment, the SQPT could also contribute to efforts to make assisted fertility treatments more patient-friendly. This study seeks to test this innovation by asking women assigned to perform a Quanti5 Multilevel hCG Pregnancy Test (Athenium Pharmaceuticals, LLC, Nashville, TN) at home on a weekly basis for up to 4 weeks after egg retrieval/embryo transfer or intrauterine insemination.
The investigators hypothesize that the test, which can be used at home by women, will provide confirmation of the presence of a pregnancy compared with standard serum hCG testing because 1) it has sensitivity and specificity that correlates well with serum testing, and 2) it can be used at home and thus earlier to determine presence of hCG.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semi-quantitative urine pregnancy test | Other | Device: Semi-quantitative urine pregnancy testSemi-quantitative urine pregnancy test (Quanti5 Multilevel hCG Pregnancy Test) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Planning embryo transfer or intrauterine insemination (IUI)
- Agrees to return for a series of follow-up visits
- Willing to follow provider instructions regarding use of at-home pregnancy test
- Has not already participated in this study (each woman can only participate once)
- Able to read and write in English
Key exclusion criteria (6 listed)
- Does not agree to return for a series of follow-up visits
- Not willing to follow provider instructions regarding use of at-home pregnancy test
- Has already participated in this study (each woman can only participate once)
- Not able to read and write in English
- Not willing to provide an address and/or telephone number to be contacted for purposes of follow-up
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 urine pregnancy testAlso: Quanti5 Multilevel hCG Pregnancy Test | Device | Semi-quantitative urine pregnancy test |
Primary outcome
Proportion of SQPT results that accurately monitor pregnancy
Time frame: 6 weeks
Participants will have follow-up visits that include serum hCG testing and ultrasounds to confirm pregnancy. Will be able to compare these results to the results of the at-home pregnancy test.
3 secondary outcomes
Feasibility of women using this test at home
Time frame: 6 weeks
Acceptability of semi-quantitative pregnancy test
Time frame: 6 weeks
Effectiveness of written instructions and provider's counseling
Time frame: 6 weeks
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 May 2014.
- Derived from this study: PubMed 28830483Shochet T, Comstock IA, Ngoc NTN, Westphal LM, Sheldon WR, Loc LT, Blum J, Winikoff B, Blumenthal PD. Results of a pilot study in the U.S. and Vietnam to assess the utility and acceptability of a multi-level pregnancy test (MLPT) for home monitoring of hCG trends after assisted reproduction. BMC Womens Health. 2017 Aug 22;17(1):67. doi: 10.1186/s12905-017-0422-y.
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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.
Lynn Westphal, MD principal investigator
Division of Reproductive Endocrinology and Infertility Stanford University School of Medicine
Paul Blumenthal, MD, MPH principal investigator
Dept of Obstetrics and Gynecology, Stanford University, Stanford University School of Medicine
Wendy Sheldon, MPH, MSW, PhD principal investigator
Gynuity Health Projects
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-quantitative urine pregnancy test in people with Embryo Transfer and Intrauterine Insemination (IUI), run by Gynuity Health Projects at 1 site 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 7 inclusion and 6 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Proportion of SQPT results that accurately monitor pregnancy (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01919502, which also lists 1 linked publication.
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 May 2014.