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Trial registered on ANZCTR


Registration number
ACTRN12622000488707
Ethics application status
Approved
Date submitted
15/02/2022
Date registered
28/03/2022
Date last updated
15/06/2022
Date data sharing statement initially provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating device to assess correlation of blood and urine hormone levels
Scientific title
Correlation of concentration of fertility hormones in serum and their metabolites in urine among patients under assisted reproductive technology (ART) treatment
Secondary ID [1] 305639 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CART
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Subfertility 324159 0
Condition category
Condition code
Reproductive Health and Childbirth 321632 321632 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective, non-interventional, single arm, single center study on an in vitro diagnostic device.
Kinder is a non-invasive in vitro diagnostic device for measuring urinary fertility hormones. Patients will collect the first-pass urine in the morning and measure their urine fertility hormones. The readout from Kinder device is not visible to patients and will be transmitted to investigator via patients’ smart phone and internet. No treatment related decision will be made based on urine fertility hormone values.
Patients will have routine clinic visits on Day 2, Day 8, Day 10, Day 11 (and onwards) of controlled ovarian stimulation and have their blood fertility hormones measured at the biochemical facility for ELISA analysis. Approximately 1 ml of additional blood sample will be collected by nurse or phlebotomist during clinic visits and be stored at -20 °C. The frozen serum sample will be shipped to a Mass Spectrometry facility for analysis.
Patients will be fully trained on how to use Kinder device properly by the study nurse before start of hormone monitoring. Participants will collect a first-pass urine sample on the same day as their scheduled blood tests, i.e. Day 2, 8, 10, 11 (and onwards) of their treatment cycle.
Intervention code [1] 322076 0
Not applicable
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329395 0

To evaluate the correlations between the urinary hormone levels measured by Kinder device and serum levels of hormones measured by ELISA and Mass Spectrometry:
-urinary Estrone-3-glucuronide (E1-3G) and serum Estradiol (E2)
Timepoint [1] 329395 0
Estimated 30 days from start of controlled ovarian stimulation to egg collection
Primary outcome [2] 330896 0
To evaluate the correlations between the urinary hormone levels measured by Kinder device and serum levels of hormones measured by ELISA and Mass Spectrometry:
-urinary Pregnanediol-3-glucuronide (PdG) and serum Progesterone (P4)
Timepoint [2] 330896 0
Estimated 30 days from start of controlled ovarian stimulation to egg collection
Primary outcome [3] 330897 0
To evaluate the correlations between the urinary hormone levels measured by Kinder device and serum levels of hormones measured by ELISA and Mass Spectrometry:
-urinary Luteinizing Hormone (LH) and serum LH.
Timepoint [3] 330897 0
Estimated 30 days from start of controlled ovarian stimulation to egg collection
Secondary outcome [1] 407565 0
To evaluate the correlation of urinary levels of E1-3G and serum levels of E2 with ovarian follicle number and sizes obtained through transvaginal ultrasound
Timepoint [1] 407565 0
Estimated 30 days from start of controlled ovarian stimulation to egg collection

Eligibility
Key inclusion criteria
1. Female patients scheduled to receive controlled ovarian stimulation treatment in the context of treatment with assisted reproductive technology (ART)
2. Ethnicity: Caucasian
3. Age: 28-38
4. BMI: 18-28
5. Regular length of menstrual cycle (24-35 days)
6. GnRH-antagonist for down regulation
Minimum age
28 Years
Maximum age
38 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Consumes more than 10 standard drinks per week during COS
2. Current smoker
3. Metabolic diseases such as diabetes, insulin resistance, renal or liver disorder.
4. Currently under Cortisol treatment
5. Use of recreational drugs (via oral history)
6. Illiterate in English
7. No access to smart phone that is compatible with Kinder App and/or is not connected to the internet

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
• Correlation (Spearman and Pearson) coefficients and confidence internals will be calculated using Fisher’s exact method
• Due to the dependence among the data points within individual patient (e.g. each patient’s multiple-visit measurements), a mixed model may be used for parametric analysis of correlation. The confidence interval of the correlation coefficient should be calculated using multi-stage bootstrapping. Due to the small sample size, mixed model might not converge, in which case the correlations estimated from Fisher’s exact method will be used solely.
• A regression model will be developed to predict the relative changes of serum hormone levels based on changes of urinary hormone levels.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
7/12/2022
Actual
Date of last data collection
Anticipated
6/01/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22294 0
Fertility Specialists WA - Claremont
Recruitment postcode(s) [1] 35792 0
6010 - Claremont

Funding & Sponsors
Funding source category [1] 309998 0
Commercial sector/Industry
Name [1] 309998 0
Merck Healthcare KGaA
Country [1] 309998 0
Germany
Primary sponsor type
Other
Name
Fertility Specialists of WA
Address
25 Queenslea Drive
Claremont WA 6010
Country
Australia
Secondary sponsor category [1] 311048 0
None
Name [1] 311048 0
Address [1] 311048 0
Country [1] 311048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309708 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 309708 0
35 Stirling Highway, Perth Western Australia 6009
Ethics committee country [1] 309708 0
Australia
Date submitted for ethics approval [1] 309708 0
22/02/2022
Approval date [1] 309708 0
19/04/2022
Ethics approval number [1] 309708 0

Summary
Brief summary
Hormonal testing can be performed at different stages during ovarian stimulation, either alone or combined with ultrasound (Kwan et al., 2014). Currently, hormonal testing is mostly performed via serum-based hormonal assay in clinical practice. Levels of Estradiol (E2), Luteinizing Hormone (LH) and Progesterone (P4) can provide information on ovarian response to stimulation, risk of ovarian hyperstimulation syndrome (OHSS), drug regimen required (type of gonadotrophin and type of protocol), whether dose adjustment of gonadotrophins is needed during treatment and optimal time to trigger follicular maturation (Kwan et al., 2014; Meyer et al., 2015; The ESHRE Guideline Group On Ovarian Stimulation et al., 2020).
Kinder is a non-invasive in vitro diagnostic device for measuring urinary fertility hormones (FSH, LH, Estrone-3-glucuronide (E1-3G) and Pregnanediol-3-glucuronide (PdG)). The assay test system is for use by both health care professionals in a clinical setting and non-professionals in a home care setting under the guidance of a health care professional. Results will be sent, as de-identified data, to be interpreted by a health care professional as an aid to clinical decisions (Planet Innovation Regulatory Strategy Plan version 3.0).
Correlation of serum concentration of fertility hormones and their urinary metabolites represents one of the critical data gaps in incorporating the use of Kinder device into the daily practice of ART treatment. This study will provide pilot data on such correlation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115114 0
Prof Roger Hart
Address 115114 0
Fertility Specialists WA
25 Queenslea Drive
Claremont WA 6010
Country 115114 0
Australia
Phone 115114 0
+61 402155808
Fax 115114 0
Email 115114 0
[email protected]
Contact person for public queries
Name 115115 0
Roger Hart
Address 115115 0
Fertility Specialists WA
25 Queenslea Drive
Claremont WA 6010
Country 115115 0
Australia
Phone 115115 0
+61 8 9284 2333
Fax 115115 0
Email 115115 0
[email protected]
Contact person for scientific queries
Name 115116 0
Roger Hart
Address 115116 0
Fertility Specialists WA
25 Queenslea Drive
Claremont WA 6010
Country 115116 0
Australia
Phone 115116 0
+61 8 9284 2333
Fax 115116 0
Email 115116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are no plans at this time and patient consent is required for data sharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.