None listed
Conditions
Interventions
Intervention1: 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.
Control Intervention1: Serum
Sponsors
Mankind Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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
| Measure | Time frame |
|---|---|
| To determine the sensitivity of the OvaNews kit in identifying the LH surge.Timepoint: 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.Timepoint: 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.Timepoint: 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).Timepoint: 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. | — |
Countries
India
Contacts
Public ContactSandeep Yadav
Mankind Pharma Limited
Outcome results
None listed