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

NCT05634850 | Unknown

• 1 other identifier: 470_1036
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Kinder DEVICE

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.

Eligibility Criteria

• Age: 30 Years - 40 Years
• Gender Eligibility Details: Female only as device test female fertility hormones
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Planet Innovation: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: September 9, 2022
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)