Evaluation of the accuracy of Inito Fertility Monitor

Not Applicable

Completed

• Conditions: Female infertility; Urological and Genital Diseases

• Registration Number: ISRCTN15534557
• Lead Sponsor: Inito

Brief Summary

2021 Preprint results in https://doi.org/10.1101/2021.05.11.21257023 (added 14/03/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36654688/ Results from a technology verification cohort of blood samples collected from 20 new users of the Inito Fertility Monitor following the same protocol as the primary cohort (added 23/01/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37286704/ (added 08/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-06
• Study Start: 2020-12-17
• Last Update Posted: 20 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 177

Inclusion Criteria

1. Women aged between 21 and 45 years
2. Menstruation cycle length of 21 to 42 days
3. Willing to provide written informed consent to participate in the study and comply with the investigational procedures

Exclusion Criteria

1. Have a condition that is known to be contra-indicated in pregnancy
2. Using or have used in their last 2 cycles, hormonal contraceptives, including oral, emergency oral, implants, patches, transdermal injections, vaginal ring, or progesterone intrauterine systems (IUS)
3. Using or have used in the last 2 cycles, infertility medications or hormone replacement therapy containing luteinizing hormone (LH) or human chorionic gonadotropin (hCG)
4. Taking clomiphene citrate or other ovulation induction drugs
5. Are using any treatment which may affect the menstrual cycle
6. Have recently been pregnant, miscarried, or breastfeeding
7. Have been diagnosed with polycystic ovarian syndrome (PCOS)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Device readings of luteinizing hormone (LH), estradiol glucuronide (E3G), and pregnanediol glucuronide (PdG) measured using the Inito Fertility Monitor, Clearblue Fertility Monitor, and ELISA with urine samples collected daily for the course of 1 menstrual cycle

Secondary Outcome Measures

Name	Time	Method
<br> 1. User feedback on the sufficiency of data measured using a questionnaire at the end of 1 menstrual cycle<br> 2. Lifestyle or infertility related conditions measured using an onboarding questionnaire at baseline<br>