Prevalence of Polycystic Ovary Syndrome In Trinidad

NCT05937360 | Unknown

• 1 other identifier: CREC-SA.1723/08/2022
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

According to World Health Organization (WHO), in 2010, Polycystic Ovarian Syndrome (PCOS) affected approximately 116 million women worldwide (3.4% of the population). It has been considered one of the most common causes of female infertility and the most common endocrine disorder. The standard diagnosis for the syndrome dates back to international conferences organized by the National Institutes of Health (NIH) in 1990 and the Rotterdam European Society of Human Reproduction and Embryology/ American Society for Reproductive Medicine (ESHRE/ASRM) sponsored PCOS consensus workshop group in 2003 and 2004. Clinical manifestations of the disease may include menstrual irregularities, amenorrhea, ovulation-related infertility, polycystic ovaries, and signs of androgen excess such as acne and hirsutism. This condition may also lead to chronic diseases such as obesity, type 2 diabetes (T2D), dyslipidaemia, and cardiovascular events. Despite the increasing knowledge concerning PCOS, the global picture of the disorder is deficient in a number of geographic regions. Understanding the global prevalence will help to better assess the public health and economic implications of PCOS in Trinidad, allow for improved screening methods, help elucidate the underlying factors and foster improved understanding of the molecular mechanisms in improving the evolutionary process.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Prevalence of PCOS and its symptoms

  To determine the prevalence of PCOS in Trinidad, data collection will include blood collection to assess hormones, thyroids, AMH, IR and other parameters as listed in the procedure. Additionally, participants will be issued a questionnaire (see attached) to assess their demographics, history of medical conditions, sexual activity, medications, contraceptive methods, Menes history, weight, height, waist to hip ratio, physical check for hirsutism and acanthosis will be checked for using various approved scales as provided in the questionnaire. The hyperandrogenic features will be evaluated using the modified Ferriman-Gallwey Hirstism Score. Mental health will be assessed using BECKS inventory. Physical activity would be assessed using SF-12 scale. Menstrual irregularities will be assessed using the Ruta Menorrghia Scale

  1 year

Interventions

cross-sectional community based study OTHER

Participants (women between the ages of 18 and 45 years) are selected randomly throughout various regions of Trinidad. Every 10th house from the selected regions would be assessed.

Also known as: retrospective study

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female, ages 18 to 45 years., all ethnic backgrounds.
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Female, ages 18 to 45 years., all ethnic backgrounds

You may qualify if:

• Female, ages 18 to 45 years., all ethnic backgrounds.
• The participants must have at least one of the following two features:
• i) Dermatological signs or complains of clinical hyperandrogenism such as unwanted facial or body hair, loss of scalp hair (alopecia) or persistence acne (pimple).
• ii) Signs or complains of ovulatory dysfunction such as irregular menses (oligomenorrhoea, amenorrhea or polymenorrhoea), history of anovulation or ultrasonographic findings of polycystic ovarian morphology.

You may not qualify if:

• Women less than 18 years or older than 45 years
• Women who are pregnant at the time of evaluation
• Postmenopausal women
• Women who had undergone hysterectomy and/or bilateral oophorectomy
• Anything that would place the individual at increased risk or preclude the individuals compliance with or completion of the study.
• Unwillingness to participate or difficulty understanding the consent process or the study objectives and requirements.

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

The University of the West Indies

Saint Augustine, 0000, Trinidad and Tobago

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, buffy coat

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Retrospective Studies

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; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Cohort Studies; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Stephanie Dr Mohammed, Ph.D.

CONTACT

18687955950; stephanie.mohammed@sta.uwi.edu

Venkatesan Dr Sundaram, Ph.D.

CONTACT

18687274802; venkatesan.sundaram@sta.uwi.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 10, 2023
• Study Start: January 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 years

Locations

TR (1)