Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Follicle-stimulating hormone (FSH) and estrogen (E3G) changes will predict the onset of the fertile window at least 5 days before ovulation in participants with confirmed ovulation
研究概览
简要总结
The Quantum Menstrual Health Monitoring Study will measure four key reproductive hormones in the urine to characterize patterns that predict and confirm ovulation, referenced to serum hormones and the gold-standard of the ultrasound day of ovulation in participants with regular cycles. These normal cycles will provide a reference for comparison to irregular cycles in polycystic ovarian syndrome (PCOS) and athletes. Clinical signs in the menstrual cycle (e.g. menstrual bleeding, temperature) as well as vital sign and sleep patterns will also be referenced to hormonal changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Regularly menstruating, PCOS or athlete participants aged 18-45
- •Negative pregnancy test at the beginning and at the end of each cycle
- •Cycle lengths 24-34 days
- •Knowledge of previous 3 cycle lengths
- •Able to travel to Calgary Clinic for regular ultrasounds during the study period
排除标准
- •For regular cycles
- •Anovulation in the last 3 cycles
- •Currently or in the previous 3 months, on medications that are known to impair or stimulate ovulation (e.g. oral contraceptives, ovulation stimulants, etc)
- •Known conditions that impair ovulation or fertility: polycystic ovarian syndrome, endometriosis, pelvic inflammatory disease in the last year, pituitary adenomas, exclusively breastfeeding
- •Previous surgeries impacting the menstrual cycle: hysterectomy, bilateral oophorectomy
- •Currently pregnant
- •For PCOS and athlete groups:
- •Currently or in the previous 3 months, on medications that are known to impair or stimulate ovulation (e.g. oral contraceptives, ovulation stimulants, etc)
- •Known conditions that impair ovulation or fertility: pelvic inflammatory disease in the last year, pituitary adenomas, exclusive breastfeeding
- •Previous surgeries impacting the menstrual cycle: hysterectomy, bilateral oophorectomy
- •Currently pregnant
结局指标
主要结局
Follicle-stimulating hormone (FSH) and estrogen (E3G) changes will predict the onset of the fertile window at least 5 days before ovulation in participants with confirmed ovulation
时间窗: 1 year
FSH and E3G changes on the Mira monitor will predict the beginning of the fertile window
The rise in urine progesterone will confirm ovulation in all participants who have ovulated based on ultrasound
时间窗: 1 year
The progesterone (PDG) rise on the Mira monitor will accurately confirm ovulation within 3-5 days of the ultrasound-day of ovulation
The rise and fall of urine luteinizing hormone will predict of ovulation in all participants with confirmed ovulation
时间窗: 1 year
The LH surge on the Mira monitor will accurately predict ovulation within 1-2 days referenced to the ultrasound-day of ovulation
次要结局
- Menstrual bleeding scores will be correlated with changes in progesterone(1 year)
- Temperature rise will confirm ovulation in participants who have ovulated on ultrasound(1 year)
研究者
Paul Yong
Associate Professor
University of British Columbia