NCT05634850

Evaluating the Usability of the Product Kinder System Trial, Home Based Hormone for In-Vitro Fertilization (IVF) Monitoring System.

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Planet Innovation · Industry
• Sex: Female
• Age: 30 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fertility Disorders

Interventions

Type	Name	Description
DEVICE	Kinder	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.

Timeline

• Start date: 2022-09-09
• Primary completion: 2023-06-09
• Completion: 2023-06-09
• First posted: 2022-12-02
• Last updated: 2022-12-02

Locations

1 site across 1 country: Singapore