To evaluate the Clinical Performance of OvaNews (Ovulation Detection Kit) for Identification of the Urinary LH Surge in Regularly Menstruating Women of Reproductive Age
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female subjects aged 18 to 45 years at the time of enrollment.
- •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.
- •Subjects who have experienced spontaneous menstrual cycles not induced by hormonal therapy for at least three consecutive months prior to screening.
- •Subjects who are not currently pregnant or lactating, as confirmed by medical history and/or urine pregnancy test at screening.
- •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.
- •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.
- •Subjects willing to avoid excessive fluid intake 02 hours prior to urine sample collection during the testing period.
- •Subjects willing and able to maintain accurate daily records of urine test results and related study information.
- •Subjects willing to report to the study site within 24 to 48 hours after obtaining a positive urine LH result for transvaginal sonography.
排除标准
- •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.
- •Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
- •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.
- •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.
- •History of ovarian surgery, oophorectomy, or known ovarian pathology (e.g., ovarian cysts requiring treatment) that may affect ovulatory function.
- •Known infertility or currently undergoing fertility treatment, including assisted reproductive technologies.
- •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.
- •Known renal disease or conditions that may affect urine concentration or hormone excretion.
- •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.
- •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.
- •Participation in another clinical study or clinical performance evaluation involving an investigational product or device within 30 days prior to screening.
研究者
Dr Maya Sharma
R P Memorial hospital