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NCT Number: NCT06164132

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Cairo University

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evaluation

Other

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

Primary outcomes

  1. Phenotypes of PCOS

    Time frame: 4 months

    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).

  2. Body mass index (BMI)

    Time frame: 4 months

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

  3. Waist hip ratio (WHR)

    Time frame: 4 months

    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. Total and regional fat mass

    Time frame: 4 months

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

  5. Total and regional lean mass

    Time frame: 4 months

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

  6. Ovarian volume

    Time frame: 4 months

    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.

  7. Peak systolic velocity (PSV)

    Time frame: 4 months

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

  8. End diastolic velocity (EDV)

    Time frame: 4 months

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

  9. Resistive index (RI)

    Time frame: 4 months

    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

  10. Pulsatility index (PI)

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Helwan University
  • National Research Centre, Egypt

Registry information

Official study title

The Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes: An Observational Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2023
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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