Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes

NCT ID: NCT06164132

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2023-10-31

Brief Summary

The study aimed to explore the impact of obesity on both body composition and ovarian Doppler parameters across various phenotypes of females diagnosed with polycystic ovarian syndrome (PCOS). Additionally, the investigation seeked to establish correlations between these parameters and their prevalence concerning the clinical criteria of PCOS.

Detailed Description

Polycystic ovarian syndrome (PCOS) is a complex and multifactorial condition characterized by endocrinological, reproductive, metabolic, and biochemical abnormalities, affecting 12% to 21% of reproductive-aged females. It has emerged as a significant global public health concern. However, variations in diagnostic criteria and patient selection have led to considerable discrepancies in the absolute prevalence of PCOS and its temporal trends. Previous studies have examined ovarian volume and blood flow indices in both obese and non-obese females with PCOS, albeit employing different criteria for obesity classification. Notably, none have compared these parameters across normal weight, overweight, and obese PCOS females. Therefore, the current study aims to explore the impact of obesity on body composition and ovarian Doppler parameters within distinct PCOS phenotypes. An additional objective is to assess correlations between anthropometric, body composition, and ovarian Doppler parameters and the prevalence of PCOS symptoms.

Conditions

Polycystic Ovary Syndrome; Obesity

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Normal Weight group

Their BMI ranged from 18.5 to 24.9 kg/m2.

Evaluation

Intervention Type: OTHER

Evaluation through PCOS Phenotypes, measurements of Body weight, height, waist and hip circumferences, Dual-energy X-ray absorptiometry, and Sonographic examination.

Overweight group

Their BMI ranged from 25 to 29.9 kg/m2.

Evaluation

Intervention Type: OTHER

Evaluation through PCOS Phenotypes, measurements of Body weight, height, waist and hip circumferences, Dual-energy X-ray absorptiometry, and Sonographic examination.

Obese group

Their BMI was ≥ 30 kg/m2.

Evaluation

Intervention Type: OTHER

Evaluation through PCOS Phenotypes, measurements of Body weight, height, waist and hip circumferences, Dual-energy X-ray absorptiometry, and Sonographic examination.

Interventions

Evaluation

Evaluation through PCOS Phenotypes, measurements of Body weight, height, waist and hip circumferences, Dual-energy X-ray absorptiometry, and Sonographic examination.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ranged from 18 to 40 years old.
• Individuals with Polycystic Ovary Syndrome (PCOS) should exhibit at least two of the three features outlined in the Rotterdam criteria for diagnosis, encompassing oligo- or anovulation, clinical and/or biochemical indications of hyperandrogenism, and the presence of polycystic ovaries as identified through ultrasonography.

Exclusion Criteria

• Congenital adrenal hyperplasia
• Thyroid dysfunction
• Hyperprolactinemia
• Androgen-secreting tumors
• Cushing syndrome
• Undergoing any medical therapy for the treatment of PCOS or for weight loss.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Helwan University

OTHER

Sponsor Role: collaborator

National Research Centre, Egypt

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Doaa A. Osman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Safenaz Y. El Sherity, Assis. Prof.

Role: PRINCIPAL_INVESTIGATOR

National Research Centre, Egypt

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004609

Identifier Type: -

Identifier Source: org_study_id