Embryo TransferNCT01846403
Feasibility and Acceptability of Using the Semi-quantitative Pregnancy Test in an Assisted Fertility Setting
A study testing Semi-quantitative urine pregnancy test in people with Embryo Transfer, run by Gynuity Health Projects at 1 site in Vietnam.
Trial summary
Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, we 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo Transfer
- 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
- 50 participants
- Where
- 1 siteVietnam
- Study dates
- Jun 2013to Dec 2013
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Eligible for assisted fertility treatment according to hospital guidelines
- Agrees to have blood drawn several times for serum hCG tests
- Agrees to return for a series of follow-up visits
- Willing to follow provider instructions regarding use of at-home pregnancy test
- 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
- Women not eligible for assisted fertility treatment
- Women who do not agree to have blood drawn several times for serum hCG tests
- Women who do not agree return for a series of follow-up visits
- Women unable to follow provider instructions regarding use of at-home pregnancy test
- Women unable to provide contact information
- Women unable to sign the consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Using the Semi-quantitative Pregnancy Test to Replace Sequential Serum hCG Testing in an Assisted Fertility Setting
Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, we 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, 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 dBest® semi-quantitative urine panel test (AmeriTekInc, Seattle WA, USA)at home on a weekly basis for up to 4 weeks after embryo transfer.
We 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. Furthermore, a pregnancy can be assured only when a yolksac or embryo could be identified thus women have to wait for a period of 2-3 weeks after the next menses expected.
Read more
We hypothesize that women seeking assisted fertility treatments will be able to monitor their hCG at home as well. Further, we plan to develop revised instructions to better suit the needs and questions we think would be relevant to women desiring to use this test as part of assisted fertility services.
We hypothesize that the simple instructions we will develop for use in this study will enable women to use the test on their own. Provider counseling will complement these instructions and contribute to overall quality of care given to each participant.
- Conditions
- Embryo Transfer
- 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 (dBest One Step hCG Panel Test Kit)
| Study group | Role | What they receive |
|---|---|---|
| Semi-quantitative pregnancy test | Other | Semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) Receives: Device: Semi-quantitative urine pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Document whether continuing pregnancy can be successfully monitored at home using a semi-quantitative pregnancy test
Measured: 6 weeks
Secondary outcomes (3)
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.
Measured: 6 weeks
Women's acceptability of using pregnancy tests at home instead of standard clinic-based monitoring after embryo transfer
Measured: 6 weeks
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
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 posted3 May 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionDec 2013
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nguyen Thi Nhu Ngoc, MD, Principal investigator, Center for Research and Consultancy in Reproductive HealthLy Thai Loc, MD, Principal investigator, Hungvuong HospitalTara Shochet, PhD, MPH, Principal investigator, Gynuity Health ProjectsPaul Blumenthal, MD, MPH, Principal investigator, Stanford UniversityBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846403
- Sponsor's protocol ID
- 6002
- Status last verified
- May 2014
- First submitted
- 1 May 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 the Semi-quantitative Pregnancy Test to Replace Sequential Serum hCG Testing in an Assisted Fertility Setting
- ClinicalTrials.gov ID
- NCT01846403
- Acronym / sponsor ID
- 6002
- Conditions
- Embryo Transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 May 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, we 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, 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 dBest® semi-quantitative urine panel test (AmeriTekInc, Seattle WA, USA)at home on a weekly basis for up to 4 weeks after embryo transfer.
We 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. Furthermore, a pregnancy can be assured only when a yolksac or embryo could be identified thus women have to wait for a period of 2-3 weeks after the next menses expected.
We hypothesize that women seeking assisted fertility treatments will be able to monitor their hCG at home as well. Further, we plan to develop revised instructions to better suit the needs and questions we think would be relevant to women desiring to use this test as part of assisted fertility services.
We hypothesize that the simple instructions we will develop for use in this study will enable women to use the test on their own. Provider counseling will complement these instructions and contribute to overall quality of care given to each participant.
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 pregnancy test | Other | Device: Semi-quantitative urine pregnancy testSemi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible for assisted fertility treatment according to hospital guidelines
- Agrees to have blood drawn several times for serum hCG tests
- Agrees to return for a series of follow-up visits
- Willing to follow provider instructions regarding use of at-home pregnancy test
- Willing to provide an address and/or telephone number to be contacted for purposes of follow-up
Key exclusion criteria (6 listed)
- Women not eligible for assisted fertility treatment
- Women who do not agree to have blood drawn several times for serum hCG tests
- Women who do not agree return for a series of follow-up visits
- Women unable to follow provider instructions regarding use of at-home pregnancy test
- Women unable to provide contact information
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: (dBest One Step hCG Panel Test Kit) | Device | Semi-quantitative pregnancy test |
Primary outcome
Document whether continuing pregnancy can be successfully monitored at home using a semi-quantitative pregnancy test
Time frame: 6 weeks
3 secondary outcomes
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.
Time frame: 6 weeks
Women's acceptability of using pregnancy tests at home instead of standard clinic-based monitoring after embryo transfer
Time frame: 6 weeks
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
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.
Nguyen Thi Nhu Ngoc, MD principal investigator
Center for Research and Consultancy in Reproductive Health
Ly Thai Loc, MD principal investigator
Hungvuong Hospital
Tara Shochet, PhD, MPH 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, run by Gynuity Health Projects at 1 site in Vietnam.
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 6 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 Vietnam. 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?
Document whether continuing pregnancy can be successfully monitored at home using a semi-quantitative pregnancy test (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 NCT01846403, 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.