The most common endocrine condition affecting women of reproductive age is polycystic ovarian syndrome (PCOS), formerly known as polycystic ovarian disease (PCOD). Global prevalence estimates vary from 4% to 21%, depending on the demographic and diagnostic criteria used Azziz R et al.(2016)[1]. It is distinguished by a varied presentation that includes polycystic ovarian morphology (PCOM) on ultrasound imaging, clinical and/or biochemical hyperandrogenism (hirsutism, acne, and androgenic alopecia), and irregular menstruation (oligomenorrhea or amenorrhoea) Teede HJ et al. (2018)[2]. In addition to its effects on reproduction, PCOS is linked to insulin resistance, obesity, metabolic syndrome, dyslipidaemia, and an elevated risk of cardiovascular disease and type 2 diabetes mellitus (T2DM) Kakoly NS et al.(2018)[3]. Environmental variables, neuroendocrine dysregulation, and genetic susceptibility interact intricately in the multifactorial pathophysiology of PCOS. Increased ovarian and adrenal androgen production, altered gonadotropin secretion (increased luteinizing hormone to follicle-stimulating hormone ratio), and insulin resistance are the hallmarks of hyperandrogenism and chronic anovulation Xu Y et al. (2022) [4]. These processes maintain follicular arrest, which may explain the distinctive polycystic ovarian shape seen on ultrasonography. Clinical factors were the primary basis for PCOS diagnosis in the past, but as time has gone on, imaging modalities, especially ultrasonography, have taken centre stage in diagnostic algorithms. The most often used diagnostic criteria were set by the 2003 Rotterdam consensus, which required the presence of at least two of the following three characteristics: (1) polycystic ovarian morphology on ultrasound; (2) clinical and/or biochemical hyperandrogenism; and (3) oligo- or anovulation[10]. Rotterdam defines PCOM as having at least 12 follicles with a diameter of 2 to 9 mm and/or an ovarian volume more than 10 mL in at least one ovary Christ JP et al. (2023) [5]. Advances in ultrasound technology, namely the use of high-frequency transvaginal probes (≥8 MHz), have led to a revisitation of the follicle number threshold used to define PCOM. A higher follicular number per ovary (FNPO) threshold—≥20 follicles—is advised by the 2014 Androgen Excess and PCOS Society and the 2018 International Evidence-Based PCOS Guidelines in order to take into consideration the enhanced resolution of contemporary equipment Di Michele S et al. (2025)[6]. Because PCOM and normal pubertal physiology overlap, these recommendations further emphasise that ultrasonography should not be utilised as the exclusive diagnostic method in teenagers. Christ JP et al. (2023) [5] Ultrasound diagnosis of PCOM has limitations despite its widespread use. First, especially in younger women, PCOM is seen in 20–30% of eumenorrheic women who do not have other PCOS symptoms. Second, ovarian morphology and measurement accuracy can be affected by a number of variables, including age, body mass index (BMI), ethnicity, use of hormonal contraceptives, and sonographer experience Lujan ME et al. (2013)[7]. Third, repeatability may be impacted by intra- and inter-observer variations in follicle counts, particularly in ovaries with elevated FNPO. The most sensitive and specific ultrasonography marker for PCOS, according to recent systematic reviews and meta-analyses, is FNPO, which outperforms ovarian volume and stromal echogenicity. Pea J et al. (2024)[8] The necessity for standardised imaging protocols is highlighted by the notable variation seen among studies with regard to ultrasonic settings, probe frequencies, counting methods, and diagnostic thresholds. According to clinical viewpoints, precise PCOM identification by ultrasonography can direct early diagnosis, accelerate metabolic screening, and enable quick action to avoid long-term complications. On the other hand, excessive use of ultrasonography without the proper clinical connection might result in overdiagnosis, needless worry, and overtreatment. Therefore, for a precise diagnosis and patient-centered therapy, sonographic results must be integrated with clinical and biochemical parameters. The prevalence of PCOS seems to be rising in India, maybe as a result of dietary changes, sedentary lifestyles, and urbanisation. Prevalence rates range from 9.13% to 36%, according to studies from different Indian states; geographical variations are caused by variations in diagnostic standards and methodology. In many tertiary care settings, knowledge, early detection, and standardised diagnostic techniques are still below ideal levels despite this high incidence. Because it is widely accessible, non-invasive, and reasonably priced, ultrasonography is a useful diagnostic adjunct in these situations. Azziz R et al.(2016)[1] In a cohort of 250 women of reproductive age, this study is being carried out in a tertiary teaching hospital in Bharuch, India, with the goals of assessing the diagnostic utility of ultrasonography in the diagnosis of PCOD/PCOS and establishing a correlation between sonographic characteristics and clinical manifestations. This study aims to improve evidence-based diagnostic procedures, lower variability, and encourage early, precise detection of PCOS in Indian women by analysing the agreement between clinical, biochemical, and imaging results OBJECTIVES Primary Objective: Correlate sonographic features (FNPO, ovarian volume, stromal characteristics) with clinical features (menstrual patterns, hyperandrogenism, BMI). Secondary Objectives: 1. Determine the prevalence of PCOM using conventional vs. updated FNPO thresholds. 2. Assess diagnostic performance (sensitivity, specificity, PPV, NPV) of ultrasound alone vs. combined with clinical features for diagnosing Rotterdam-defined PCOS.

Study Design & Population Prospective observational study from April 2024 to April 2025 at Dr Kiran C Patel Medical College & Research Institute, Bharuch. All consenting women (n = 250, age 15–45) presenting with menstrual irregularities, infertility, or hyperandrogenic symptoms were included. Exclusions encompassed known endocrine disorders (e.g., Cushing’s, CAH), pregnancy/lactation, recent hormone therapy, or acute pelvic pathology. Clinical & Biochemical Assessment Participants filled out standardised questionnaires on their demographics, menstrual history, BMI, infertility, and hyperandrogenic symptoms (measured by modified Ferriman-Gallwey; mFG ≥8 indicated hirsutism). When clinically required and accessible, biochemical tests (testosterone, LH, FSH, glucose, and lipids) were carried out. Ultrasound Protocol Participants received ultrasound treatment during the early follicular phase (Days 3–5) (TVUS if possible, otherwise transabdominal). FNPO (max of two ovaries), ovarian volume using the ellipsoid formula, vascularity, and stromal echogenicity were among the measurements. Probe frequency and other scan parameters were noted. PCOM was categorised using both (a) the revised thresholds (FNPO ≥20–25 follicles per ovary) and (b) the traditional Rotterdam criteria (FNPO ≥12 and/or OV >10 mL). Statistical Analysis Data were analyzed using SPSS v26. Descriptive stats: means ± SD, counts, percentages. Chi-square or Fisher’s exact tests evaluated associations; logistic regression estimated odds for PCOM given clinical features. Diagnostic accuracy indices (sensitivity, specificity, PPV, NPV) were calculated for ultrasound alone and in combination with clinical features (e.g., oligomenorrhea + FNPO ≥12). Significance was set at p < 0.05. RESULTS Table 1: Baseline Characteristics of Participants (n = 250) Characteristic Mean ± SD (Range) / n (%) Age (years) 26.9 ± 5.8 (15–45) Age group • 18–35 years 180 (72%) • >35 years 70 (28%) BMI (kg/m²) 26.1 ± 4.9 BMI ≥25 kg/m² 98 (39%) Presenting complaints* • Menstrual irregularity 170 (68%) • Infertility 105 (42%) • Hirsutism/acne 102 (41%) • Incidental pelvic pain/routine check 20 (8%) *Multiple responses possible. The research participants' demographic profile and presenting complaints are compiled in this table. The majority (72%) were between the ages of 18 and 35, with a mean age of 26.9 years. 39% had a BMI ≥25 kg/m², and the mean was 26.1 kg/m². The most frequent presenting symptom was irregular menstruation (68%), which was followed by hirsutism/acne (41%), and infertility (42%). A little percentage (8%) showed up by chance during a regular gynaecological examination or pelvic discomfort assessment. Table 2: Clinical Findings (n = 250) Finding n (%) Oligomenorrhea or amenorrhea 170 (68%) Clinical hyperandrogenism (mFG ≥8 or acne) 102 (41%) Infertility (primary or secondary) 105 (42%) This table presents the key clinical features observed in the cohort. Oligomenorrhea or amenorrhea was present in 68% of women, while clinical hyperandrogenism — defined as a modified Ferriman–Gallwey score ≥8 or acne — was noted in 41%. Infertility, both primary and secondary, was reported in 42% of participants.

Table 3: Sonographic Findings (n = 250) Sonographic Parameter Mean ± SD / n (%) PCOM – FNPO ≥12 or OV >10 mL (Rotterdam) 145 (58%) PCOM – Higher FNPO threshold (≥20–25) 105 (42%) Ovarian volume (mL) – maximum of two ovaries 11.9 ± 5.4 OV >10 mL 115 (46%) Increased stromal echogenicity 85 (34%) Increased stromal vascularity (Doppler) 70 (28%) The ultrasonography features of the study population's ovaries are listed in this table. 58% of women satisfied the criteria for polycystic ovarian morphology (PCOM) according to the Rotterdam criteria (FNPO ≥12 or OV >10 mL). The frequency dropped to 42% with a higher FNPO threshold (≥20–25 follicles per ovary, depending on the kind of probe). 46% had an ovarian capacity more than 10 mL, with the mean maximum ovarian volume being 11.9 mL. Of the subjects, 34% showed enhanced stromal echogenicity, and 28% showed increased stromal vascularity on Doppler imaging. Table 4: Correlation Between Sonographic and Clinical Features Clinical Feature n PCOM FNPO ≥12 n (%) PCOM Higher FNPO Threshold n (%) p-value Oligomenorrhea/amenorrhea 170 126 (74%) 94 (55%) <0.001 Clinical hyperandrogenism 102 70 (69%) — 0.02 BMI ≥25 kg/m² 98 — — OV higher (13.1 vs 10.4 mL), p=0.01 The relationship between the presence of PCOM and important clinical characteristics is assessed in this table. Using the higher FNPO criteria, 55% of women with oligomenorrhea/amenorrhea had PCOM, whereas 74% of them had PCOM based on FNPO ≥12 (p<0.001). PCOM was substantially correlated with clinical hyperandrogenism (69%, p=0.02). Mean ovarian volumes were considerably greater in women with a BMI ≥25 kg/m² (13.1 vs. 10.4 mL, p=0.01), but BMI was not linked to FNPO independently after controlling for age. Table 5: Diagnostic Performance of Ultrasound Morphology for PCOS Criterion Sensitivity (%) Specificity (%) PPV NPV FNPO ≥12 ~78 ~65 0.58 — Higher FNPO threshold ~62 ~82 — — Oligomenorrhea + FNPO ≥12 — — 0.76 — This table describes how well ultrasound-based morphology diagnoses PCOS, which is described by the Rotterdam criteria as having at least two of three clinical, biochemical, and ultrasound characteristics. FNPO ≥12 had a positive predictive value (PPV) of 0.58, a sensitivity of around 78%, and a specificity of 65%. Raising the FNPO threshold reduced sensitivity to 62% while increasing specificity to about 82%. In this sample, the PPV rose to 0.76 when FNPO ≥12 was combined with clinical characteristics such oligomenorrhea

The mean age of the 250 women in this study was 26.9 years, and the majority (72%) were in the 18–35 age range, which corresponds to the peak reproductive age group that is usually impacted by polycystic ovarian syndrome (PCOS) Azziz R et al.(2016)[1]. This demographic distribution is in line with epidemiological statistics from India and throughout the world, which show that women between the ages of 20 and 30 have the highest prevalence of PCOS. 39% of people were overweight or obese, and the mean BMI was 26.1 kg/m2, which supports the established link between metabolic risk factors and PCOS. Increased insulin resistance, hyperandrogenism, and irregular menstruation have all been associated with obesity in PCOS, and there is evidence that ovarian morphological alterations may worsen if a person's BMI is ≥25 kg/m² Barber TM et al. (2019)[9]. The most frequent presenting symptom was irregular menstruation (68%), which was followed by hirsutism/acne (41%), and infertility (42%). This distribution of symptoms is consistent with the clinical profile found in comparable studies from South Asia, where amenorrhoea or oligomenorrhea are more common Teede HJ et al. (2018)[2]. Given that ovulatory dysfunction is still the predominant cause of anovulatory infertility, the fact that 42% of individuals experienced infertility underscores the serious reproductive consequences of PCOS. Xu Y et al. (2022)[4]. 41% had clinical hyperandrogenism, and 68% had oligomenorrhea or amenorrhoea. Our cohort's prevalence of hyperandrogenism is lower than that of certain Western cohorts, where rates surpass 60%, but it is equivalent to that seen in previous Indian research (35–50%). Gill H et al. (2012)[10] Ethnic variations in hair growth patterns, hormone profiles, and diagnostic criteria for the modified Ferriman–Gallwey score may be the cause of this variance. Using the Rotterdam criteria of follicle number per ovary (FNPO ≥12 or ovarian volume >10 mL), ultrasound showed polycystic ovarian morphology (PCOM) in 58% of women. The incidence decreased to 42% when a stronger FNPO criterion (≥20–25 follicles) was applied. This decrease is in line with the growing knowledge that using lower cutoffs might cause enhanced transducer resolution to overstate follicle numbers Di Michele S et al. (2025)[6]. Increased stromal echogenicity and vascularity were seen in 34% and 28% of cases, respectively, and the mean maximal ovarian capacity was 11.9 mL, with 46% above 10 mL. The usefulness of ovarian volume and stromal indices as supplementary indicators is supported by these sonographic characteristics, especially in overweight women who showed noticeably greater mean ovarian volumes (p=0.01). In support of the substantial association between ovulatory dysfunction and morphological alterations, the correlation analysis revealed that oligomenorrhea/amenorrhea was highly linked with PCOM (74% at FNPO ≥12 vs. 55% at higher FNPO, p<0.001) Bachanek M et al. (2015) [11]. In line with androgen-driven follicular arrest mechanisms, clinical hyperandrogenism was also substantially linked to PCOM (69%, p=0.02). Despite the fact that, after controlling for age, obesity did not independently correlate with FNPO, its correlation with ovarian volume raises the possibility that obesity may have an impact on stromal hypertrophy. Di Michele S et al. (2025)[6] While increasing FNPO thresholds increased specificity (82%) at the price of sensitivity (62%), FNPO ≥12 produced a diagnostic sensitivity of 78% and specificity of 65%. Dewailly et al. [16] suggested higher criteria to prevent overdiagnosis in young, healthy women with naturally high follicle numbers, and this trade-off is consistent with their findings. The positive predictive value increased to 0.76 when clinical symptoms like oligomenorrhea were combined with FNPO ≥12, confirming that combining clinical and sonographic criteria maximises diagnostic accuracy. Our study's conclusions have many therapeutic ramifications. First, the prevalence of PCOS may be inflated if ultrasound morphology is the only factor used, especially when older FNPO cutoffs are used, especially in adolescents and young adults. Second, the correlations found between hyperandrogenism, irregular menstruation, and PCOM underscore the diversity of PCOS phenotypes and the necessity of specialised treatment approaches. Third, increased ovarian volume in women who are overweight supports early lifestyle therapies by highlighting the metabolic-reproductive interaction of PCOS Escobar-Morreale HF et al. (2018)[12]. Our findings support the increasing body of evidence suggesting the use of ultrasonography in PCOS diagnosis should depend on the unique environment, especially in locations with low resources where access to biochemical testing may be limited Paalanne M et al.(2021)[13]. To prevent both overdiagnosis and underdiagnosis, it is nevertheless essential to standardise FNPO levels while taking equipment resolution and population-specific norms into account.

Among the 250 women in this cohort, young women of reproductive age were most likely to have polycystic ovarian syndrome; the most common presentations were irregular menstruation, infertility, and clinical hyperandrogenism. The Rotterdam FNPO ≥12 criterion for ultrasound-based diagnosis showed great sensitivity but modest specificity, whereas a higher FNPO threshold increased specificity at the expense of sensitivity. Clinical hyperandrogenism, oligomenorrhea/amenorrhea, and polycystic ovarian morphology are strongly correlated, which emphasises how crucial it is to combine clinical and sonographic data for a precise diagnosis. Furthermore, the metabolic–reproductive interaction of PCOS and the necessity of early lifestyle therapies are highlighted by the discovery of increased ovarian volume in overweight women. These findings support the need for context-specific diagnostic strategies and the cautious FNPO cutoff setting based on population characteristics and ultrasonography technology.

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