| CTRI Number |
CTRI/2026/01/102089 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Prospective study to evaluate the Clinical Performance of OvaNews (Ovulation Detection Kit) for Identification of the Urinary LH Surge in Regularly Menstruating Women of Reproductive Age |
|
Scientific Title of Study
|
To evaluate the Clinical Performance of OvaNews (Ovulation Detection Kit) for Identification of the Urinary LH Surge in Regularly Menstruating Women of Reproductive Age |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maya Sharma |
| Designation |
Principal Investigator |
| Affiliation |
R P Memorial hospital |
| Address |
R P memorial hospital, sector 5-tha-7,8,9, Jawahar Nagar, Jaipur, Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9571557346 |
| Fax |
|
| Email |
kamleshsharmasms2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhaumik Mody |
| Designation |
Head Clinical Research & RWE- Medical Affairs |
| Affiliation |
Mankind Pharma Limited |
| Address |
262 Okhla Industrial Estate, Phase III, New Delhi-110020
New Delhi
DELHI
110020
India |
| Phone |
01146541111 |
| Fax |
|
| Email |
bhaumik.mody@mankindpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandeep Yadav |
| Designation |
Managing Director |
| Affiliation |
Manentia Research Pvt. Ltd |
| Address |
CP-11, Phase III, RIICO, Sitapura Industrial Area, Jaipur , Rajasthan 302022, India
Jaipur
RAJASTHAN
302022
India |
| Phone |
7290072455 |
| Fax |
|
| Email |
syadav@manentiaresearch.com |
|
|
Source of Monetary or Material Support
|
| Mankind Pharma Limited
262, Okhla Industrial Estate, Phase III,
New Delhi, India – 110020 |
|
|
Primary Sponsor
|
| Name |
Mankind Pharma Limited |
| Address |
262, Okhla Industrial Estate, Phase III, New Delhi - 110020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maya Sharma |
RP Memorial Hospital |
Sector 5, THA 7,8,9, Jawahar Nagar, Jaipur, Rajasthan 302004
Jaipur
RAJASTHAN |
9571557346
kamleshsharmasms2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swastic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Regularly Menstruating Women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ovanews |
serum LH testing and Urine testing will be done from Day 11 to Day 16. Start date of menstruation cycle will be considered as Day 1 Baseline visit. |
| Comparator Agent |
Serum LH testing |
Serum LH testing |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female subjects aged 18 to 45 years at the time of enrollment.
2. Subjects with a regular menstrual cycle, defined as a cycle length of 24 to 35 days with a
variation of no more than plus minus 3 days over the preceding three menstrual cycles.
3. Subjects who have experienced spontaneous menstrual cycles not induced by hormonal
therapy for at least three consecutive months prior to screening.
4. Subjects who are not currently pregnant or lactating, as confirmed by medical history and/or
urine pregnancy test at screening.
5. Subjects willing and able to provide their daily urine sample approx. 5 ml and their blood
sample approx. 2 ml for testing the OvaNews Ovulation Detection Kit and for Serum LH
test, according to the study instructions.
6. Subjects willing to collect urine sample and provide blood sample at a fixed time between 1000
AM and 0800 PM, maintaining the same time each day during the testing period.
7. Subjects willing to avoid excessive fluid intake 02 hours prior to urine sample collection
during the testing period.
8. Subjects willing and able to maintain accurate daily records of urine test results and related
study information.
9. Subjects willing to report to the study site within 24 to 48 hours after obtaining a positive urine LH result for transvaginal sonography.
10. Subjects who are willing and able to provide written informed consent prior to participation
in any study related procedures. |
|
| ExclusionCriteria |
| Details |
1. Females with irregular menstrual cycles, defined as cycle length less than 24 days or more than 35 days, or cycle variability more than ±3 days over the preceding three cycles.
2. Pregnant or breastfeeding women, or women planning to become pregnant during the study
period.
3. Use of hormonal contraceptives, hormone replacement therapy, ovulation induction agents, or any hormonal medications known to affect the hypothalamic–pituitary–ovarian axis within
the last three months prior to screening.
4. Known or suspected endocrine disorders that may interfere with ovulation or LH secretion,
including but not limited to polycystic ovary syndrome (PCOS), hyperprolactinemia, thyroid
disorders, or pituitary abnormalities.
5. History of ovarian surgery, oophorectomy, or known ovarian pathology (e.g., ovarian cysts
requiring treatment) that may affect ovulatory function.
6. Known infertility or currently undergoing fertility treatment, including assisted reproductive technologies.
7. Use of medications that may interfere with LH levels or urinary hormone excretion, such as
gonadotropins or GnRH analogues, within three months prior to enrollment.
8. Known renal disease or conditions that may affect urine concentration or hormone excretion.
9. Active genitourinary tract infection or vaginal bleeding (other than normal menstruation) at the time of testing that may interfere with urine testing or sonographic assessment.
10. Any medical, psychiatric, or social condition that, in the opinion of the investigator, may
compromise subject safety, interfere with study compliance, or affect the reliability of study
results.
11. Participation in another clinical study or clinical performance evaluation involving an
investigational product or device within 30 days prior to screening. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the clinical performance of the OvaNews (Ovulation Detection Kit) to detect
the urinary luteinizing hormone (LH) surge in regularly menstruating women of reproductive age. |
Baseline/Enrolment visit - Day 1 of Mensuration Cycle
Treatment Phase - Day 11 to Day 16 (Urine testing and Serum LH testing)
End Of treatment - Transvaginal sonography to confirm ovulatory status. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the sensitivity of the OvaNews kit in
identifying the LH surge. |
Baseline/Enrolment visit - Day 1 of Mensuration Cycle
Treatment Phase - Day 11 to Day 16 (Urine testing & Serum LH testing)
End Of treatment - Transvaginal sonography to confirm ovulatory status. |
To assess the predictive value of the OvaNews kit in
identifying the fertile window. |
Baseline/Enrolment visit - Day 1 of Mensuration Cycle
Treatment Phase - Day 11 to Day 16 (Urine testing & Serum LH testing)
End Of treatment - Transvaginal sonography to confirm ovulatory status. |
To assess usability & user interpretation of the OvaNews
kit under intended-use conditions. |
Baseline/Enrolment visit - Day 1 of Mensuration Cycle
Treatment Phase - Day 11 to Day 16 (Urine testing & Serum LH testing)
End Of treatment - Transvaginal sonography to confirm ovulatory status. |
To assess the correlation between serum LH measurements
with urinary LH surge (OvaNews Kit). |
Baseline/Enrolment visit - Day 1 of Mensuration Cycle
Treatment Phase - Day 11 to Day 16 (Urine testing & Serum LH testing)
End Of treatment - Transvaginal sonography to confirm ovulatory status. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/02/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, non-interventional, observational study aimed to evaluate the performance of the OvaNews (Ovulation Detection Kit) to identify the urinary luteinizing hormone (LH) surge in regularly menstruating women of reproductive age under real-world conditions.
Eligible subjects will be enrolled after obtaining written informed consent. Following screening and baseline assessments, subjects will be instructed to provide their urine and serum samples once-daily for testing urinary LH surge using the OvaNews kit and serum LH measurements from Serum LH test during the peri-ovulatory period of a single menstrual cycle.
Urine collection and Serum collection will commence on a cycle-specific start day, determined based on the subject’s average menstrual cycle length (e.g., Day 11 for a 28-day cycle). Testing will be performed at a fixed time each day between 10:00 AM and 8:00 PM, with the same time maintained throughout the testing period. Subjects will be advised to avoid excessive fluid intake prior to urine sample collection to prevent dilution of urinary LH.
Urine testing and Serum LH testing will be continued for up to 6 consecutive days or until a positive result is obtained, whichever occurs first. A positive result is defined as the appearance of two pink lines at both the Control (C) and Test (T) regions, indicating detection of the urinary LH surge and initiation of the fertile window. Upon obtaining a positive result, further urine testing will be discontinued.
Subjects who obtain a positive OvaNews result will be required to report to the study site within 24 to 48 hours for transvaginal sonography. Sonographic assessment will be performed to evaluate peri-ovulatory changes, including evidence of dominant follicle rupture, as part of safety assessment and physiological confirmation of ovulation-related events. All test results, clinical assessments, and sonography findings will be recorded in the study records. Subject participation will conclude following completion of post-positive assessments and safety review. |