Fertility DisordersNCT05634850
Evaluating the Usability of the Product Kinder System Trial, Home Based Hormone for In-Vitro Fertilization (IVF) Monitoring System.
An observational study of Fertility Disorders, run by Planet Innovation at 1 site in Singapore.
Trial summary
In-vitro fertilisation (IVF) treatment involves women undergoing hormone stimulation (drug dosing) to produce more oocytes (eggs) to increase their chances of fertilisation. The information that IVF clinicians currently collect on a woman's hormonal response to IVF drug dosing comes from in-clinic blood testing. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- Kinder
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Sep 2022to 9 Jun 2023
- 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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 30-40 years older undergoing a controlled ovarian stimulation cycle as part of assisted reproductive treatment.
Who may be able to join
- Women undergoing controlled ovarian stimulation treatment
- 30 to 40 years old (inclusive)
- Willingness to comply with study procedures for collection and testing of urine
Who cannot join
- Illiterate in English
- No access to smart phone that is compatible with App and/or is not connected to the internet
- Patients who are diabetic (Type I and Type II), have insulin resistance or a renal/liver disorder
- Patients who have taken oral contraceptives up to 4 days before the first stimulation day of the cycle
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Serene Lai, +65 6772 2681, xinhui@nus.edu.sg
Peng Cheang Wong
About this study
Official title: A Pilot Study: A Prospective, Longitudinal, Observational Study, Evaluating the Usability of the Product Kinder System Trial, Home Based Hormone for In-Vitro Fertilization (IVF) Monitoring System.
In-vitro fertilisation (IVF) treatment involves women undergoing hormone stimulation (drug dosing) to produce more oocytes (eggs) to increase their chances of fertilisation. The information that IVF clinicians currently collect on a woman's hormonal response to IVF drug dosing comes from in-clinic blood testing. This requires patients to make a visit to the IVF clinic every few days to have the blood samples taken. The blood is then analysed in a laboratory for the hormone levels and the results are then sent back to the clinic. This monitoring process of frequent onsite visits and blood draws can often be quite inconvenient and disruptive for patients.
This observational study will assess a non-invasive in vitro diagnostic (IVD) device for measuring the common fertility hormones in urine. The test system is for use by both healthcare professionals in a clinical setting and nonprofessionals in a home care setting under the guidance of a health care professional. This study will provide pilot data on the usability of the IVD device from the intended end users as well as the correlation of urinary metabolite levels as measured by the IVD device and the serum concentration as measured by blood analysers.
- Conditions
- Fertility Disorders
- Being tested
- Kinder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinderDevice
Participants will test at their urine with at home with in the device. Results are sent via an app back to the clinic for reporting.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the usability of Kinder by patients undergoing controlled ovarian stimulation cycle
Patients will perform tests with the Kinder system and complete a usability questionnaire on their experience.
Measured: A single controlled ovarian stimulation cycle, typically up to 20 days
Correlation of fertility hormone serum and urinary metabolites
Correlation of E2, P4 and LH and their urinary metabolites (E1-3G, PdG and LH)
Measured: A single controlled ovarian stimulation cycle, typically up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start9 Sep 2022
- Primary completion9 Jun 2023 (estimated)
- Study completion9 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Planet Innovation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634850
- Sponsor's protocol ID
- 470_1036
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: A Prospective, Longitudinal, Observational Study, Evaluating the Usability of the Product Kinder System Trial, Home Based Hormone for In-Vitro Fertilization (IVF) Monitoring System.
- ClinicalTrials.gov ID
- NCT05634850
- Acronym / sponsor ID
- 470_1036
- Conditions
- Fertility Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Planet InnovationIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 9 Jun 2023 (estimated)
- Study completion
- 9 Jun 2023 (estimated)
- First posted
- 2 Dec 2022 (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.
In-vitro fertilisation (IVF) treatment involves women undergoing hormone stimulation (drug dosing) to produce more oocytes (eggs) to increase their chances of fertilisation. The information that IVF clinicians currently collect on a woman's hormonal response to IVF drug dosing comes from in-clinic blood testing. This requires patients to make a visit to the IVF clinic every few days to have the blood samples taken. The blood is then analysed in a laboratory for the hormone levels and the results are then sent back to the clinic. This monitoring process of frequent onsite visits and blood draws can often be quite inconvenient and disruptive for patients.
This observational study will assess a non-invasive in vitro diagnostic (IVD) device for measuring the common fertility hormones in urine. The test system is for use by both healthcare professionals in a clinical setting and nonprofessionals in a home care setting under the guidance of a health care professional. This study will provide pilot data on the usability of the IVD device from the intended end users as well as the correlation of urinary metabolite levels as measured by the IVD device and the serum concentration as measured by blood analysers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 30-40 years older undergoing a controlled ovarian stimulation cycle as part of assisted reproductive treatment.
Key inclusion criteria (3 listed)
- Women undergoing controlled ovarian stimulation treatment
- 30 to 40 years old (inclusive)
- Willingness to comply with study procedures for collection and testing of urine
Key exclusion criteria (4 listed)
- Illiterate in English
- No access to smart phone that is compatible with App and/or is not connected to the internet
- Patients who are diabetic (Type I and Type II), have insulin resistance or a renal/liver disorder
- Patients who have taken oral contraceptives up to 4 days before the first stimulation day of the cycle
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 |
|---|---|---|
| KinderParticipants will test at their urine with at home with in the device. Results are sent via an app back to the clinic for reporting. | Device | – |
Primary outcome
To evaluate the usability of Kinder by patients undergoing controlled ovarian stimulation cycle
Time frame: A single controlled ovarian stimulation cycle, typically up to 20 days
Patients will perform tests with the Kinder system and complete a usability questionnaire on their experience.
Correlation of fertility hormone serum and urinary metabolites
Time frame: A single controlled ovarian stimulation cycle, typically up to 20 days
Correlation of E2, P4 and LH and their urinary metabolites (E1-3G, PdG and LH)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Disorders, run by Planet Innovation at 1 site in Singapore.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Dec 2022. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the usability of Kinder by patients undergoing controlled ovarian stimulation cycle (time frame: A single controlled ovarian stimulation cycle, typically up to 20 days). The study lists 2 primary outcomes in all. 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 2 Dec 2022.