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临床试验/NCT02999568
NCT02999568Unknown不适用

Open Study to Examine How Different Levels of Physical Activity Impact the Ovarian Reserve During the Pre-menopausal Period

Meir Medical Center0 个研究点目标入组 100 人开始时间: 2017年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Levels of anti-mullerian hormone

研究概览

简要总结

The purpose of this study is to examine how different levels of physical activity impact the ovarian reserve during the pre-menopausal period

详细描述

Two groups are included:

  1. The study group: women between 20-35 years of age who practice high level of physical activity, as defined by International Physical Activity Questionnaire , for the past 3 years
  2. The control group: women between 20-35 years of age who practice low level of physical activity, as defined by International Physical Activity Questionnaire , for the past 3 years

Women who meet the criteria for inclusion for will be recruited to the study after signing a consent form. Recruitment will be done through sport centers. The control group will include women being examined in gynecologic emergency department, after signing a consent form, if they meet the control group's inclusion criteria. These women will be asked to fulfill the International Physical Activity Questionnaire and additional questionnaire regarding relevant demographic and medical information (see below). Blood samples to anti-mullerian hormone , leptin, and hormonal profile will be obtained in day 3 of menstruation. Ultrasound will be performed to measure Antral Follicular count and ovarian blood flow.

Data collection:

  1. Demographic information on age, weight, height, BMI, marital status
  2. Medical information regarding chronic diseases and medications
  3. Obstetrical history
  4. Information regarding physical activities in the version of International Physical Activity Questionnaire .
  5. Information about menstrual behavior: irregularity (yes/no) frequency (less than 21 days between 21-35 days, over 35 days), menstrual duration (less than 3 days 3-7 days, or over 7 days) bleeding amount according to the number of pads per day (up to 1, 2, 4 or 5 pads).
  6. Hormonal profile - Follicle-stimulating hormone , Luteinizing hormone , progesterone, Estradiol, Thyroid-stimulating hormone .
  7. Antral Follicle Count, Anti-mullerian hormone
  8. Leptin levels -reflecting metabolic changes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Study group:
  • Women between 20-35 years of age who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years
  • Regular menstruation
  • Control group:
  • Women between 20-35 years of age who practice low level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years
  • Regular menstruation

排除标准

  • Polycystic ovary syndrome
  • Endometriosis
  • Hyper/hypothyroidism
  • BMI>25, BMI<18
  • Active or past eating disorder

结局指标

主要结局

Levels of anti-mullerian hormone

时间窗: 3 days after period

Number of Antral Follicle Count

时间窗: 3 days after period

次要结局

  • levels fo Luteinizing hormone(3 days after period)
  • Levels of Follicle-stimulating hormone(3 days after period)
  • Levels of progesterone(3 days after period)
  • Levels of estradiol(3 days after period)
  • Levels of Thyroid-stimulating hormone(3 days after period)
  • Levels of leptin(3 days after period)
  • Menstrual duration(3 days after period)
  • frequency of bleeding in every menstruation(3 days after period)
  • amount of bleeding in every menstruation(3 days after period)

研究者

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

Yael Pasternak

MD

Meir Medical Center

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