None listed
Conditions
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.
Interventions
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
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.
Sponsors
Fertility Specialists of WA
Eligibility
Sex/Gender
All
Age
28 Years to 38 Years
Healthy volunteers
No
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
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
Outcome results
None listed