Clinical Trial: Ultrasound Characterization of Ovarian Follicle Dynamics in Women With Amenorrhea

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Ultrasound Characterization of Ovarian Follicle Dynamics in Women With Amenorrhea

Brief Summary: In women with regular menstrual cycles, antral follicles have been shown to grow in synchronous cohorts, called waves, 2-3 times in a menstrual cycle. It is unknown whether these waves of follicle growth also occur in women with amenorrhea or if there is abnormal/absent follicle growth. Further, oligo- or amenorrhea has been associated with metabolic disturbances, such as over- or under-nutrition, central obesity and insulin resistance. Yet, mechanisms whereby metabolic factors influence folliculogenesis in women are poorly understood. To understand potential mechanisms, the investigators plan to characterize follicle growth dynamics in women with or without regular menstrual cycles and identifying key metabolic differences in these women which may be important in normal follicle development and fertility.

Detailed Summary:

In the ovaries, eggs rest in fluid filled sacs called follicles. When follicles grow they form small fluid-filled cysts that can be easily seen when we use ultrasound to view the ovaries. In women with regular menstrual cycles, groups of 10 to 20 follicles grow and regress at 2 or 3 different times during their cycle (usually over a 28- day period). Several of these follicles grow to a stage where they begin to develop the potential to ovulate - but in general only one follicle is chosen to ovulate. Thus, at any given time during the menstrual cycle, numerous fluid-filled follicles can be visualized in a woman's ovaries at various stages of development using transvaginal ultrasonography. In women with absent or infrequent menstrual cycles, very little is known about the growth patterns of their follicles and how factors such as metabolic hormones, might play a role in the failure to ovulate. Being underweight or overweight increases your chances of having irregular or absent menstrual cycles and that a history of abnormal reproductive function compounds a woman's risk for chronic diseases such as infertility, diabetes, hypertension, atherosclerosis and certain cancers. This is particularly the case for women with polycystic ovary syndrome (PCOS) that have menstrual cycles that appear to worsen or improve depending on their body weight and metabolic status. PCOS is an endocrine disorder that affects 6-12% of reproductive-aged women within the general population. The hallmark features of PCOS are menstrual irregularity, increased levels of androgens, and polycystic ovaries. The current diagnostic criteria require 2 out of 3 of these features to be present for the diagnosis, therefore a number of phenotypes of PCOS exist. However, the metabolic and reproductive differences across the phenotypic spectrum of PCOS are not well understood. Women with PCOS characteristically have polycystic ovaries, where up to 10 times more fol
Sponsor: Cornell University

Current Primary Outcome:

• Follicle number [ Time Frame: 4-5 weeks ]
  The number of all antral follicles in each ovary will be determined using ultrasonography for each participant. Changes in follicle number over time will be compared between groups.
• Follicle diameter [ Time Frame: 4-5 weeks ]
  The diameter of all follicles >2mm will be determined using ultrasonography for each participant. Changes in follicle diameter over time will be compared between groups.

Original Primary Outcome: Follicle diameter and number [ Time Frame: 4-5 weeks ]

Current Secondary Outcome:

• Ovarian Volume [ Time Frame: 4-5 weeks ]
  The size of each ovary will be determined using ultrasonography for each participant during study participation and compared between groups.
• Anti-Müllerian hormone [ Time Frame: 4-5 weeks ]
  The serum AMH concentration will be determined during study participation and assessed in association with the change in follicle number, diameter and between groups.
• Serum FSH concentration [ Time Frame: 4-5 weeks ]
  The serum FSH concentration will be determined during study participation and assessed in association with the change in follicle number, diameter and between groups.
• Serum LH concentration [ Time Frame: 4-5 weeks ]
  The serum FSH concentration will be determined during study participation and assessed in association with the change in follicle number, diameter and between groups.
• Serum progesterone concentration [ Time Frame: 4-5 weeks ]
  The serum progesterone concentration will be determined during study participation, assessed in association with luteal dynamics and compared between groups.
• LH-FSH ratio [ Time Frame: 4-5 weeks ]
  The ratio of circulating LH to FSH concentrations will be determined for each participant and compared between groups.
• Insulin sensitivity [ Time Frame: 1 day ]
  Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared between groups.
• Androgen concentrations [ Time Frame: 1 day ]
  Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared between groups.
• Menstrual Cycle Length [ Time Frame: 4-5 weeks ]
  Average menstrual cycle length as determined by self-reported history and the menstrual cycle length during study participation will be determined and compared between groups.
• Hirsutism [ Time Frame: 1 day ]
  Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared between groups.
• Serum markers of metabolic syndrome [ Time Frame: 1 day ]
  Lipids, glucose and HbA1C concentrations will be determined and compared between groups.
• Blood Pressure [ Time Frame: 1 day ]
  Blood pressure will be determined and compared between groups.
• Body mass index [ Time Frame: 1 day ]
  The ratio of weight to height will be determined and compared between groups.
• Waist-to-hip ratio [ Time Frame: 1 day ]
  The ratio of waist circumference to hip circumference will be determined and compared between groups.
• Body fat distribution [ Time Frame: 1 day ]
  Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared between groups.

Original Secondary Outcome: Differences body composition across women with regular versus irregular menstrual cycles [ Time Frame: 1 day ]

Information By: Cornell University

Dates:
Date Received: August 20, 2013
Date Started: September 2011
Date Completion: December 2017
Last Updated: August 11, 2016
Last Verified: August 2016