Ultrasound Characterization of Ovarian Follicle Dynamics in Women With Amenorrhea

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Cornell University
Sponsor:
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01927432
First received: August 20, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition
Oligomenorrhea
Amenorrhea
Polycystic Ovary Syndrome (PCOS)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Ultrasound Characterization of Ovarian Follicle Dynamics in Women With Amenorrhea

Resource links provided by NLM:


Further study details as provided by Cornell University:

Primary Outcome Measures:
  • Follicle number [ Time Frame: 4-5 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Ovarian Volume [ Time Frame: 4-5 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The ratio of circulating LH to FSH concentrations will be determined for each participant and compared between groups.

  • Insulin sensitivity [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared between groups.

  • Androgen concentrations [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Lipids, glucose and HbA1C concentrations will be determined and compared between groups.

  • Blood Pressure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Blood pressure will be determined and compared between groups.

  • Body mass index [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The ratio of weight to height will be determined and compared between groups.

  • Waist-to-hip ratio [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The ratio of waist circumference to hip circumference will be determined and compared between groups.

  • Body fat distribution [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared between groups.


Biospecimen Retention:   Samples With DNA

Blood serum, subcutaneous fat


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Regular menstrual cycles
Adult women will be assigned to this category if they report a history of regular menstrual cycles.
Irregular menstrual cycles
Adult women will be assigned to this category if they report a history of irregular menstrual cycles, including women with a pre-existing diagnosis of PCOS.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women must be able to transport to Cornell University in Ithaca, NY. Eligible participants are between 18-38 years with a BMI of 18.5 kg/m2 or higher. Women are screened and enrolled following consent based on their response to our advertisements. Enrollment is restricted to the geographical area.

Criteria

Inclusion Criteria:

  • Between 18 and 38 years
  • BMI ≥ 18.5 kg/m2

Either:

  • Regular menstrual cycles (21-35 days);
  • Irregular menstrual cycles (>36 days) with or without a previous diagnosis of PCOS from a primary care provider

Exclusion Criteria:

  • Current use of medication(s) known or suspected to interfere with reproductive function (eg. oral contraceptives) or insulin sensitivity
  • Pregnant or breastfeeding
  • Not otherwise healthy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927432

Contacts
Contact: Marla E. Lujan, PhD 607-255-3153 MEL245@cornell.edu
Contact: Heidi Vanden Brink, MS, RDMS 607-255-5983 hv63@cornell.edu

Locations
United States, New York
Human Metabolic Research Unit, Cornell University Recruiting
Ithaca, New York, United States, 14853
Contact: Erica Bender, MSN, CNM    607-255-9417    eb572@cornell.edu   
Principal Investigator: Marla E. Lujan, PhD         
Sponsors and Collaborators
Cornell University
Investigators
Principal Investigator: Marla E. Lujan, PhD Cornell University
  More Information

No publications provided

Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01927432     History of Changes
Other Study ID Numbers: IRB #: 0908000633
Study First Received: August 20, 2013
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cornell University:
Polycystic Ovary Syndrome (PCOS)
Nutrition
Metabolism
Antral follicle growth
Menstrual Cyclicity

Additional relevant MeSH terms:
Amenorrhea
Oligomenorrhea
Polycystic Ovary Syndrome
Menstruation Disturbances
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014