Early PregnancyNCT06228131
Detection of hCG in Early Pregnancy Clinical Samples
An observational study of Early Pregnancy, run by Andon Health Co., Ltd at 2 sites in China.
Trial summary
To evaluate the detection of hCG in the early pregnancy urine samples by Human chorionic gonadotropin (HCG) test system. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Early Pregnancy
- How many people
- 241 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2023to 2 Jan 2024
- How long will I take part?
- 10 Days
- 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 18 to 55 years
- Women only
- Adult
Study population: There were 241 subjects who planned to conceive but did not conceive participating in the clinical trial. Of these, 73 women successfully conceived and provided a full cycle of urine samples(10 days, from day -8 to day +1 relative to the expected period) .
Who may be able to join
- Female；
- 18-55 years of age；
- In a state of preparing for pregnancy;
- Voluntary and sign informed consent form.
Who cannot join
- Within 8 weeks of childbirth or abortion；
- The investigator has reason to believe that it is inappropriate for subjects to participate in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
First Teaching hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
Internet Hospital of Tianjin Medical University General Hospital
Tianjin
About this study
To evaluate the detection of hCG in the early pregnancy urine samples by Human chorionic gonadotropin (HCG) test system.
- Conditions
- Early Pregnancy
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 |
|---|---|---|
| subjects who provided early pregnancy urine samples | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the detection of hCG in the early pregnancy urine samples by investigational device.
Percentage Pregnancy Results (%) for early pregnancy urine samples on different days from day -8 to day +1 relative to the expected period.
Percentage Pregnancy Results (%): 79% (day -5 relative to the expected period)
Measured: 10day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Aug 2023
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early PregnancyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Andon Health Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228131
- Sponsor's protocol ID
- IHC-3000-LCFA02
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of hCG in Early Pregnancy Clinical Samples
- ClinicalTrials.gov ID
- NCT06228131
- Acronym / sponsor ID
- IHC-3000-LCFA02
- Conditions
- Early Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Andon Health Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 29 Jan 2024 (actual)
- 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.
To evaluate the detection of hCG in the early pregnancy urine samples by Human chorionic gonadotropin (HCG) test system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects who provided early pregnancy urine samples | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- There were 241 subjects who planned to conceive but did not conceive participating in the clinical trial. Of these, 73 women successfully conceived and provided a full cycle of urine samples(10 days, from day -8 to day +1 relative to the expected period) .
Key inclusion criteria (4 listed)
- Female；
- 18-55 years of age；
- In a state of preparing for pregnancy;
- Voluntary and sign informed consent form.
Key exclusion criteria (2 listed)
- Within 8 weeks of childbirth or abortion；
- The investigator has reason to believe that it is inappropriate for subjects to participate in the study.
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
To evaluate the detection of hCG in the early pregnancy urine samples by investigational device.
Time frame: 10day
Percentage Pregnancy Results (%) for early pregnancy urine samples on different days from day -8 to day +1 relative to the expected period. Percentage Pregnancy Results (%): 79% (day -5 relative to the expected period)
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 29 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Pregnancy, run by Andon Health Co., Ltd at 2 sites in China.
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 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
To evaluate the detection of hCG in the early pregnancy urine samples by investigational device. (time frame: 10day). 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 29 Jan 2024.