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Recruiting NCT05634850

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

Conditions: Fertility Disorders

Sex: Female
Ages: 30 Years – 40 Years
Enrollment: 25
Sponsor: Planet Innovation

Location: Singapore

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 treatment30 to 40 years old (inclusive)Willingness to comply with study procedures for collection and testing of urineExclusion Criteria:Illiterate in EnglishNo access to smart phone that is compatible with App and/or is not connected to the internetPatients who are diabetic (Type I and Type II), have insulin resistance or a renal/liver disorderPatients who have taken oral contraceptives up to 4 days before the first stimulation day of the cycle

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05634850). StuddyBuddy aggregates publicly available trial information.