Evaluation of the accuracy of Inito Fertility Monitor
| ISRCTN | ISRCTN15534557 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15534557 |
| Secondary identifying numbers | U85110KA2003PTC032782 |
- Submission date
- 05/12/2020
- Registration date
- 17/12/2020
- Last edited
- 08/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
The Inito Fertility Monitor is intended to be used for the measurement of hormone levels in urine samples. The system is intended for home use by people or point-of-care (POC) use by a trained health care professional as an aid in the diagnosis of infertility. The aim of this clinical study is to evaluate the performance of the Inito Fertility Monitor in the measurement of three key fertility hormones: luteinizing hormone (LH), estradiol glucuronide (E3G), and pregnanediol glucuronide (PdG) using urine samples.
.
Who can participate?
Adult women aged between 21 and 45 years of age with an average menstrual cycle length of 21 to 42 days.
What does the study involve?
Clinical performance of the Inito Fertility Monitor will be compared to two other methods for measuring hormone levels: the Clearblue Fertility Monitor and a laboratory investigation called ELISA.
Participants will collect urine samples at home every day for the duration of one menstrual cycle (the time from the first day of their period to the day before their next period) and these will be tested with Inito Fertility Monitor and Clearblue Fertility Monitor. Inito Fertility test strips and Clearblue test strips were dipped in the samples for 15 sec and after 5 min, readings from the respective devices were recorded. The samples for assessment with ELISA will be also collected from the users and transported to the investigational centre in dry ice within 30 min of collection.
What are the possible benefits and risks of participating?
Around 45-50% of women are unaware of their fertile window. The fertile window may vary depending on various factors such as age, lifestyle, or genetic predisposition. Previously it has been shown that estrone-3-glucuronide (E3G) and luteinizing hormone (LH) can be used to identify the fertile window. Also, anovulatory cycles occur in around 37-42% of natural cycles. Therefore, the confirmation of ovulation is sought after by both clinicians and patients and an additional measurement of pregnanediol-3-glucuronide (PdG) can be used to confirm ovulation. By taking part in this study, participants can identify their fertile window and hormone concentrations throughout the cycle, if their hormone fluctuations are as expected or do the hormones behave abnormally, and if their menstrual cycles are ovulatory or anovulatory.
No risks have been identified as being associated with taking part in this trial.
Where is the study run from?
Sparsh Hospital (India)
When is the study starting and how long is it expected to run for?
From June 2019 to December 2019
Who is funding the study?
Inito (India)
Who is the main contact?
Mr Siddharth Pattnaik,
siddharth@inito.com
Contact information
Scientific
Inito
2nd Floor, 44 SKS Plaza
100 Feet Road
Bengaluru
560034
India
 ORCID ID |
0000-0003-4136-5180 |
|---|---|
| Phone | +91-8766563170 |
| siddharth@inito.com |
Public
Inito
2nd Floor, 44 SKS Plaza
100 Feet Road
Bengaluru
560034
India
| ORCID ID |
0000-0003-4136-5180 |
|---|---|
| Phone | +91-8766563170 |
| siddharth@inito.com |
Study information
| Study design | Single-centre observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Home |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | Validation of Inito Fertility Monitor with respect to laboratory measures of fertility related hormones |
| Study hypothesis | The Inito Fertility Monitor can measure concentrations of urinary hormones estradiol glucuronide, luteinizing hormone, and pregnanediol glucuronide with laboratory-grade accuracy and can predict the fertile days in women accurately |
| Ethics approval(s) | Approved 21/05/2019, Sparsh Hospital Institutional Ethics Committee (146, Infantry Road, Opposite to Police Commissioner's Office, Bengaluru 560001; +91-80-61222000; enquiry@sparshhospital.com), ref: CLIN/INI/001 |
| Condition | Female infertility |
| Intervention | Urine samples were collected by each participant at home every day for the duration of one menstrual cycle. The samples were frozen by putting the samples in the cold box container provided and sent to the testing site. The box provided contained a temperature logger in order to ensure that the temperature is maintained during transport to the testing site. The testing was done at the Inito laboratory situated at Bionest, IKP Eden, 16, Bhuvanappa Layout, Tavarekere Main Rd, Bengaluru, 560029. Urine samples were tested with both the Inito Fertility Monitor and Clearblue Fertility Monitor using test strips for the respective devices. Inito Fertility test strips and Clearblue test strips were dipped in the samples for 15 sec, and, after 5 min, readings from the respective devices were recorded. Each volunteer was assigned a unique ID. 3 participants were randomly selected and samples over the course of 1 cycle for each of these participants were collected for comparison of Inito and enzyme-linked immunosorbent assay (ELISA). The samples were collected from the participants and transported to the investigational centre in dry ice within 30 min of collection. The samples were aliquoted into 2 ml tubes and stored at -20°C in order to preserve the concentration of all the hormones. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Inito Fertility Monitor |
| Primary outcome measure | 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 | 1. User feedback on the sufficiency of data measured using a questionnaire at the end of 1 menstrual cycle 2. Lifestyle or infertility related conditions measured using an onboarding questionnaire at baseline |
| Overall study start date | 15/03/2019 |
| Overall study end date | 06/12/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 |
| Total final enrolment | 177 |
| Participant 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 |
| Participant 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) |
| Recruitment start date | 06/06/2019 |
| Recruitment end date | 06/11/2019 |
Locations
Countries of recruitment
- India
Study participating centre
Opposite to Police Commissioner's Office
Bengaluru
560001
India
Sponsor information
Industry
44 SKS Plaza
100 Feet Road
Bengaluru
560034
India
| Phone | +91-9742931931 |
|---|---|
| care@inito.com | |
| Website | http://www.inito.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The datasets generated will be available upon request from Siddharth Pattnaik (siddharth@inito.com). The datasets generated contain: 1. For the comparison between ELISA and Inito Fertility Monitor (IFM), the re-predicted concentration obtained from ELISA and IFM and the correlation plots between ELISA and IFM for predicting estrone-3-glucuronide (E3G), luteinizing hormone (LH), and pregnanediol-3-glucuronide (PdG) concentrations. 2. Fertility ratings obtained from Clearblue Easy Fertility Monitor and Inito Fertility Monitor for each participant on all days of the menstrual cycle. 3. Graphs of hormone fluctuations during menstrual cycles of all the participants obtained using the Inito Fertility Monitor acquired on the Inito application. The data generated from the study is available anytime. All data generated and analyses are proprietary to Inito and will be made available for reference only. The data cannot be used as raw data for any other analysis or publication, unless already published by Inito or unless permitted by Inito. Consent from all participants has been obtained in order to use the data for publication. The participants' names have been anonymised during their inclusion in the study itself. Data pertinent to the trials (including BMI, average cycle length, lifestyle, and whether participants are trying to conceive or not) have been collected and can be made available along with the analysis as well. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Preprint results | 12/05/2021 | 14/03/2022 | No | No | |
| Other publications | 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 | 21/12/2022 | 23/01/2023 | Yes | No |
| Results article | 07/06/2023 | 08/06/2023 | Yes | No |
Editorial Notes
08/06/2023: Publication reference added.
23/01/2023: Publication reference added.
14/03/2022: The following changes have been made:
1. Preprint added.
2. The final enrolment number has been added from the reference.
14/12/2020: Trial’s existence confirmed by Sparsh Hospital Institutional Ethics Committee.
