Clinical trial NCT06164132: Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes
Official title: The Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Obesity
Keywords: Polycystic Ovary Syndrome
Obesity
Body composition
Ovarian Doppler
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Helwan University
name: National Research Centre, Egypt
First posted: 2023-12-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: They were recruited from the gynecology and infertility clinic, for Doppler sonographic examination and body composition analysis.

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.

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.

Primary outcomes:
measure: Phenotypes of PCOS
timeFrame: 4 months
measure: Body mass index (BMI)
timeFrame: 4 months
measure: Waist hip ratio (WHR)
timeFrame: 4 months
measure: Total and regional fat mass
timeFrame: 4 months
measure: Total and regional lean mass
timeFrame: 4 months
measure: Ovarian volume
timeFrame: 4 months
measure: Peak systolic velocity (PSV)
timeFrame: 4 months
measure: End diastolic velocity (EDV)
timeFrame: 4 months
measure: Resistive index (RI)
timeFrame: 4 months
measure: Pulsatility index (PI)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: National Research Centre, Egypt
name: Safenaz Y. El Sherity, Assis. Prof.
role: PRINCIPAL_INVESTIGATOR
References: