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

NCT06164132 | Completed

• 1 other identifier: P.T.REC/012/004609
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Obesity

Keywords

Polycystic Ovary Syndrome; Obesity; Body composition; Ovarian Doppler

Outcome Measures

Primary Outcomes (10)

• Phenotypes of PCOS

  The patients were categorized into four distinct phenotypes: Type I, characterized by oligomenorrhea/amenorrhea and hyperandrogenism (O+H); Type II, exhibiting polycystic ovaries and hyperandrogenism (P+H); Type III, featuring oligomenorrhea/amenorrhea and polycystic ovaries (O+P); and Type IV, presenting with oligomenorrhea/amenorrhea, polycystic ovaries, and hyperandrogenism (O+P+H).

  4 months

• Body mass index (BMI)

  The height and weight were determined for each female in the three groups to calculate her BMI = (weight in kg)/(height in m2)

  4 months

• Waist hip ratio (WHR)

  The waist and hip circumferences were taken for each female in the three groups for calculating waist and hip ratio (WHR) by dividing waist circumference (WC) on the hip circumference (HC).

  4 months

• Total and regional fat mass

  They were measured by Dual-energy X-ray absorptiometry.

  4 months

• Total and regional lean mass

  They were measured by Dual-energy X-ray absorptiometry.

  4 months

• Ovarian volume

  The ovarian volume was computed utilizing the ellipsoid formula, which involves multiplying the dimensions of length, width, and height by a constant factor of 0.523.

  4 months

• Peak systolic velocity (PSV)

  It was recorded for each female in the three groups by Color Doppler ultrasound.

  4 months

• End diastolic velocity (EDV)

  It was recorded for each female in the three groups by Color Doppler ultrasound.

  4 months

• Resistive index (RI)

  The Resistance Index (RI) was determined by dividing the difference between Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) by PSV. A lower value of RI is indicative of increased blood flow

  4 months

• Pulsatility index (PI)

  The Pulsatility Index (PI) was calculated by dividing the difference between Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) by the mean maximum flow velocity. A reduced PI value is indicative of heightened blood flow.

  4 months

Study Arms (3)

Normal Weight group

Their BMI ranged from 18.5 to 24.9 kg/m2.

Other: Evaluation

Overweight group

Their BMI ranged from 25 to 29.9 kg/m2.

Other: Evaluation

Obese group

Their BMI was ≥ 30 kg/m2.

Other: Evaluation

Interventions

Evaluation OTHER

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

Normal Weight group; Obese group; Overweight group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

They were recruited from the gynecology and infertility clinic, for Doppler sonographic examination and body composition analysis.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Helwan University: collaborator
• National Research Centre, Egypt: collaborator

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity

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; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Safenaz Y. El Sherity, Assis. Prof.

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: July 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

EG (1)