Phenotype and Epidemiology of the Polycystic Ovary Syndrome (PCOS) in Colombia (PEP - Colombia) Study.

NCT05926115 | Unknown

• 1 other identifier: 1006
• Study Type: observational
• Target: 626
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to know the prevalence of PCOS among economically productive and reproductive age women from Medellín and the Valle de Aburrá, Colombia. The main questions it aims to answer are:

1. 1.What is the phenotypic distribution of PCOS detected in women seeking medical attention as a requirement for employment in Medellín and the Valle de Aburrá, Colombia?
2. 2.What is the effect of environmental factors, such as geographical location and diet, and biological factors (such as obesity and ethnicity/race) on the prevalence and phenotype of PCOS in this populatión?

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism; Endocrine System Diseases

Keywords

Polycystic Ovary; Hyperandrogenism; Hirsutism; Oligomenorrhea; Anovulation; Menses, Irregular

Outcome Measures

Primary Outcomes (1)

• Prevalence of PCOS

  Prevalence of PCOS among a medically unselected population-based sample representing the Latino population. In addition, Percentage of participants with phenotype A, B, C or D, among participants diagnosed with PCOS.

  Six months

Secondary Outcomes (1)

• Percentage of participants with obesity, endocrine disorders, metabolic syndrome, hyperandrogenism, hirsutism, oligomenorrhea, anovulation and irregular menses

  Six months

Interventions

Diagnostic Ultrasound DIAGNOSTIC_TEST

During the initial visit, a transvaginal or transabdominal pelvic ultrasonography will be performed in all participants, based on the sexual history and consent form by trained gynecologists who are part of study investigators. A transvaginal ultrasound is the accepted and validated method to assess the ovarian morphology in the study of patients with PCOS.

Also known as: Pelvic ultrasound

Venous puncture DIAGNOSTIC_TEST

After an overnight fast of at least 6 hours (ideally), a 18 ml sample of venous blood will be collected from each study participant (i.e., the basal fasting sample). About 12 ml of the venous blood will be collected in plain tubes for serum cryopreservation and subsequent analysis, and the remainder in plain tubes for immediate glucose estimation in serum.

Also known as: Blood test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: PCOS is a female disorder
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women seeking medical attention at Colmédicos medical center as a requirement for employment in Medellín and the Valle de Aburrá, Colombia.

You may qualify if:

• Women aged 18 to 45 years.
• Participants with thyroid dysfunction on medication will be included only if their TSH level is normal (prior to or at re-evaluation)

You may not qualify if:

• a. Women who are pregnant at the time of evaluation b. Postmenopausal women
• Women who are pregnant at the time of evaluation
• Postmenopausal women

Sponsors & Collaborators

• Instituto de fertilidad humana, InSer: lead
• University of Alabama at Birmingham: collaborator
• Colmédicos S.A.S.: collaborator
• ABAD Laboratorio: collaborator

Study Sites (1)

Colmédicos S.A.S

Sabaneta, Antioquia, 055450, Colombia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism; Endocrine System Diseases; Hirsutism; Oligomenorrhea; Anovulation; Menstruation Disturbances

Interventions

Ultrasonography; Hematologic Tests

Condition Hierarchy (Ancestors)

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; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Ricardo Azziz, M.D.

  University of Alabama at Birminghan

  STUDY DIRECTOR

Central Study Contacts

Walter E Osorio, M.D

CONTACT

+57 3002213567; wosorio@inser.com.co

Maria N Posada, M.D

CONTACT

+ 57 3104324385; nposada@inser.com.co

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: July 3, 2023
• Study Start: March 4, 2023
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)