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Clinical Trials/NCT02999568
NCT02999568UnknownNot Applicable

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

Meir Medical Center0 sites100 target enrollmentStarted: February 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Primary Endpoint
Levels of anti-mullerian hormone

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Levels of anti-mullerian hormone

Time Frame: 3 days after period

Number of Antral Follicle Count

Time Frame: 3 days after period

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yael Pasternak

MD

Meir Medical Center

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