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.

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.

Study Overview

• Status: Recruiting
• Conditions: Fertility Disorders
• Intervention / Treatment: Device: Kinder

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
    • Contact: Serene Lai; Phone Number: +65 6772 2681; Email: xinhui@nus.edu.sg
    • Principal Investigator: Peng Cheang Wong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the usability of Kinder by patients undergoing controlled ovarian stimulation cycle	Patients will perform tests with the Kinder system and complete a usability questionnaire on their experience.	A single controlled ovarian stimulation cycle, typically up to 20 days
Correlation of fertility hormone serum and urinary metabolites	Correlation of E2, P4 and LH and their urinary metabolites (E1-3G, PdG and LH)	A single controlled ovarian stimulation cycle, typically up to 20 days

Collaborators and Investigators

• Sponsor: Planet Innovation

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Anticipated): June 9, 2023
• Study Completion (Anticipated): June 9, 2023

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 470_1036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No