Ultrasound Characterization of Ovarian Follicle Dynamics in Women With Amenorrhea

NCT01927432 | Completed

• 1 other identifier: IRB #: 0908000633
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Oligomenorrhea; Amenorrhea; Polycystic Ovary Syndrome (PCOS)

Keywords

Polycystic Ovary Syndrome (PCOS); Nutrition; Metabolism; Antral follicle growth; Menstrual Cyclicity

Outcome Measures

Primary Outcomes (2)

• Follicle number

  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.

  4-5 weeks

• Follicle diameter

  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.

  4-5 weeks

Secondary Outcomes (16)

• Ovarian Volume

  4-5 weeks

• Anti-Müllerian hormone

  4-5 weeks

• Serum FSH concentration

  4-5 weeks

• Serum LH concentration

  4-5 weeks

• Serum progesterone concentration

  4-5 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women must be able to transport to Cornell University in Ithaca, NY. Eligible participants are between 18-35 years with a BMI of 18 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.

You may qualify if:

• Between 18 and 35 years
• BMI ≥ 18 kg/m2
• If ≥ 21 years old, must have had healthy pelvic exam w/in past 2 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Human Metabolic Research Unit, Cornell University

Ithaca, New York, 14853, United States

Location

Related Publications (2)

• Oldfield AL, Carter FE, Reeves RE, Jarrett BY, Vanden Brink H, Lujan ME. Impact of a hypocaloric dietary intervention on antral follicle dynamics in eumenorrheic women with obesity. Hum Reprod. 2024 Apr 3;39(4):801-811. doi: 10.1093/humrep/deae017.

  PMID: 38335228 DERIVED

• Oldfield AL, Vanden Brink H, Carter FE, Jarrett BY, Lujan ME. Obesity is associated with alterations in antral follicle dynamics in eumenorrheic women. Hum Reprod. 2023 Mar 1;38(3):459-470. doi: 10.1093/humrep/dead007.

  PMID: 36708012 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum, subcutaneous fat

MeSH Terms

Conditions

Oligomenorrhea; Amenorrhea; Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Marla E. Lujan, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 22, 2013
• Study Start: September 1, 2011
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

US (1)