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临床试验/NCT05531357
NCT05531357已完成不适用

Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Antral follicle diameter

研究概览

简要总结

The research aims to characterize changes in ovarian and pituitary hormones associated with the development of ovarian follicular waves during the human menstrual cycle.

详细描述

Our laboratory's previous research has demonstrated that multiple waves of ovarian follicles develop throughout the menstrual cycle. Approximately 2/3 of women develop 2 follicle waves throughout their cycle while the remainder exhibit 3 waves of follicle growth (1,2). This study is to follow up on those findings to determine how pituitary and ovarian hormones regulate the development of follicle waves in women, with a combination of ultrasound scans and blood and urine sampling to characterize how follicles grow during the menstrual cycle in 50 women of reproductive age. Changes in follicle growth across the cycle will be compared with changes in hormone production.

The new findings will be essential for improving understanding of female reproduction, with clinical applications in contraception, fertility and menopausal care for women across their reproductive lifespan.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy biological females
  • Regular menstrual cycles (21-35 days)

排除标准

  • BMI <18 or >30
  • Pregnancy
  • Breastfeeding mothers
  • Current infertility
  • History of hysterectomy or oophorectomy
  • Reproductive health issues that can interfere with study outcomes
  • Metabolic syndrome (blood pressure, fasting glucose, fasting insulin and serum lipids measured to assess eligibility)
  • Not on any hormonal medication that affects reproduction (including hormonal contraception)
  • Hyperprolactinemia
  • Abnormal thyroid stimulating hormone assay

结局指标

主要结局

Antral follicle diameter

时间窗: One menstrual cycle (21-35 days) per volunteer

Daily diameters of individual follicles ≥ 2mm from ultrasound examination

Antral follicle count

时间窗: One menstrual cycle (21-35 days) per volunteer

Daily count of the number of follicles \>2 mm from ultrasound examination

Anti-mullerian hormone (AMH) serum level

时间窗: One menstrual cycle (21-35 days) per volunteer

Daily measurements of AMH in ng/mL

Inhibin B serum level

时间窗: One menstrual cycle (21-35 days) per volunteer

Daily measurements of inhibin B in pg/mL

Follicle stimulating hormone (FSH) serum level

时间窗: One menstrual cycle (21-35 days) per volunteer

Daily measurements of FSH in IU/L

Luteinizing hormone (LH) serum level

时间窗: One menstrual cycle (21-35 days) per volunteer

Daily measurements of LH in IU/L

Estradiol serum level

时间窗: One menstrual cycle (21-35 days) per volunteer

Daily measurements of estradiol in pg/mL

Progesterone serum level

时间窗: One menstrual cycle (21-35 days) per volunteer

Daily measurements of progesterone in ng/mL

Inhibin A serum level

时间窗: One menstrual cycle (21-35 days) per volunteer

Daily measurements of inhibin A in pg/mL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Baerwald

Associate Professor

University of Saskatchewan

研究点 (1)

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