Phenotype and Epidemiology of the Polycystic Ovary Syndrome (PCOS) in Colombia (PEP - Colombia) Study. (PEP-Colombia)
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ClinicalTrials.gov Identifier: NCT05926115 |
Recruitment Status :
Recruiting
First Posted : July 3, 2023
Last Update Posted : July 3, 2023
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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:
- 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?
- 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?
Participants will undergo anthropometric measurements and physical examination for hirsutism, acne, alopecia, acanthosis nigricans, and thyroid enlargement. During the initial visit, a transvaginal or transabdominal pelvic ultrasonography will be performed. A sample of venous blood will be collected in plain tubes for serum cryopreservation and for immediate glucose estimation. Some participants will be rescheduled for a second evaluation visit for additional assessment when they have a possible PCOs.
Condition or disease | Intervention/treatment |
---|---|
Polycystic Ovary Syndrome Hyperandrogenism Endocrine System Diseases | Diagnostic Test: Diagnostic Ultrasound Diagnostic Test: Venous puncture |
Study Type : | Observational |
Estimated Enrollment : | 626 participants |
Observational Model: | Ecologic or Community |
Time Perspective: | Prospective |
Official Title: | Phenotype and Epidemiology of the Polycystic Ovary Syndrome (PCOS) in Colombia (PEP - Colombia) Study. |
Actual Study Start Date : | March 4, 2023 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | September 30, 2023 |
- Diagnostic Test: Diagnostic Ultrasound
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.Other Name: Pelvic ultrasound
- Diagnostic Test: Venous puncture
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.Other Name: Blood test
- Prevalence of PCOS [ Time Frame: Six months ]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.
- Percentage of participants with obesity, endocrine disorders, metabolic syndrome, hyperandrogenism, hirsutism, oligomenorrhea, anovulation and irregular menses [ Time Frame: Six months ]Percentage of participants with obesity, endocrine disorders, metabolic syndrome, hyperandrogenism, hirsutism, oligomenorrhea, anovulation and irregular menses among the study population, which will also have a detailed description of their demographic characteristics
Biospecimen Retention: Samples Without DNA
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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | PCOS is a female disorder |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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)
- Participants with hyperprolactinemia will be included only if their prolactin (PRL) level is normal (prior to or at re-evaluation) b) Exclusion criteria
a. Women who are pregnant at the time of evaluation b. Postmenopausal women
Exclusion Criteria:
- Women who are pregnant at the time of evaluation
- Postmenopausal women
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05926115
Contact: Walter E Osorio, M.D | +57 3002213567 | wosorio@inser.com.co | |
Contact: Maria N Posada, M.D | + 57 3104324385 | nposada@inser.com.co |
Colombia | |
Colmédicos S.A.S | Recruiting |
Sabaneta, Antioquia, Colombia, 055450 | |
Contact: Diana Bedoya, M.D. +57 3127488026 medicolaboral@colmedicos.com |
Study Director: | Ricardo Azziz, M.D. | University of Alabama at Birminghan |
Responsible Party: | Instituto de fertilidad humana, InSer |
ClinicalTrials.gov Identifier: | NCT05926115 |
Other Study ID Numbers: |
1006 |
First Posted: | July 3, 2023 Key Record Dates |
Last Update Posted: | July 3, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Polycystic Ovary Hyperandrogenism Hirsutism |
Oligomenorrhea Anovulation Menses, Irregular |
Polycystic Ovary Syndrome Hyperandrogenism Endocrine System Diseases Syndrome Disease Pathologic Processes 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 |