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

NCT ID: NCT05634850

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2023-06-09

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.

Conditions

Fertility Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Planet Innovation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Facility Contacts

Serene Lai

Role: primary

xinhui@nus.edu.sg

+65 6772 2681

Other Identifiers

470_1036

Identifier Type: -

Identifier Source: org_study_id