Clinical trial NCT05634850: Evaluating the Usability of the Product Kinder System Trial, Home Based Hormone for In-Vitro Fertilization (IVF) Monitoring System.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fertility Disorders
Lead sponsor: Planet Innovation
Sponsor class: INDUSTRY
First posted: 2022-12-02
Enrollment: 25
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 30-40 years older undergoing a controlled ovarian stimulation cycle as part of assisted reproductive treatment.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Women undergoing controlled ovarian stimulation treatment
* 30 to 40 years old (inclusive)
* Willingness to comply with study procedures for collection and testing of urine

Exclusion Criteria:

* 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

Primary outcomes:
measure: To evaluate the usability of Kinder by patients undergoing controlled ovarian stimulation cycle
timeFrame: A single controlled ovarian stimulation cycle, typically up to 20 days
measure: Correlation of fertility hormone serum and urinary metabolites
timeFrame: A single controlled ovarian stimulation cycle, typically up to 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References: