Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age, characterized by hyperandrogenism, chronic anovulation, and polycystic ovarian morphology. It is one of the leading causes of infertility worldwide and is associated with metabolic disturbances such as insulin resistance, obesity, and dyslipidemia. The complex pathophysiology of PCOS involves disruptions in the hypothalamic-pituitary-ovarian axis, leading to hormonal imbalances that affect ovulation and fertility outcomes [1]. Thyroid dysfunction mainly subclinical Hypothyroidism is another significant endocrine disorder prevalent among women of reproductive age. Thyroid hormones play a crucial role in normal reproductive function, including the regulation of menstrual cycles, ovulation, and early pregnancy maintenance. Hypothyroidism, hyperthyroidism, and subclinical thyroid disorders can adversely affect fertility by causing menstrual irregularities, anovulation, and increased risk of miscarriage [2]. Several studies have suggested a possible association between thyroid dysfunction and PCOS. Women with PCOS appear to have a higher prevalence of thyroid disorders, especially autoimmune thyroiditis and hypothyroidism. This coexistence may exacerbate reproductive and metabolic abnormalities and adversely influence fertility outcomes [3]. The presence of thyroid dysfunction in PCOS patients can potentially worsen ovulatory dysfunction and reduce the likelihood of conception.[4] Understanding the relationship between thyroid dysfunction and fertility outcomes in women with PCOS is essential to optimize diagnostic and therapeutic strategies. It can lead to early detection and management of thyroid abnormalities, which might improve ovulation rates, pregnancy outcomes, and reduce complications during pregnancy.[5] Aim To evaluate the relationship between thyroid dysfunction and fertility outcomes in women diagnosed with Polycystic Ovary Syndrome (PCOS). Objectives 1. To determine the prevalence of thyroid dysfunction among women with PCOS attending the fertility clinic. 2. To assess the impact of thyroid dysfunction on menstrual regularity and ovulatory status in women with PCOS. 3. To analyze the association between thyroid dysfunction and clinical fertility outcomes, including conception rates and miscarriage rates, in women with PCOS.

Source of Data Data was collected from women diagnosed with PCOS who attended the Gynecology. Study Design A cross-sectional observational study design was employed to evaluate the relationship between thyroid dysfunction and fertility outcomes in women with PCOS. Study Location The study was conducted at the Department of Obstetrics and Gynecology. Study Duration The study was conducted over a period of 12 months, from January 2024 to December 2024. Sample Size A total of 200 women diagnosed with PCOS based on Rotterdam criteria were included in the study. Inclusion Criteria • Women aged 18 to 40 years diagnosed with PCOS as per Rotterdam criteria (presence of at least two of the following: oligo/anovulation, clinical or biochemical signs of hyperandrogenism, polycystic ovaries on ultrasound). • Women who consented to participate in the study. Exclusion Criteria • Women with known thyroid disorders on treatment prior to the study. • Women with other causes of infertility such as tubal block, male factor infertility, or uterine abnormalities. • Women with systemic illnesses affecting fertility - diabetes mellitus, hyperprolactinemia. • Pregnant women at the time of enrollment. Procedure and Methodology Eligible women attending the outpatient clinics were explained the purpose of the study, and informed consent was obtained. A detailed clinical history focusing on menstrual patterns, symptoms suggestive of thyroid dysfunction, and fertility history was recorded. Physical examination including anthropometric measurements and signs of hyperandrogenism was performed. All participants underwent transvaginal or pelvic ultrasonography to evaluate ovarian morphology. Blood samples were collected in the early follicular phase (days 2–5 of the menstrual cycle) for hormonal assays. Thyroid function tests including serum Thyroid Stimulating Hormone (TSH), T₃ and T₄. Additional hormonal parameters such as serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), prolactin, and serum androgens were also assessed. Fertility outcomes were assessed by evaluating menstrual regularity, ovulatory status (based on clinical history and hormonal assays), history of conception, and pregnancy outcomes including miscarriage rates. Sample Processing Blood samples were collected by venipuncture and processed as per standard laboratory protocols. Serum was separated and analyzed using chemiluminescent immunoassay (CLIA) methods. Quality control and calibration were maintained according to the manufacturer’s instructions. Statistical Methods Data were entered into Microsoft Excel and analyzed using Statistical Package for Social Sciences (SPSS) version 25. Descriptive statistics were used to summarize demographic and clinical characteristics. Continuous variables were expressed as mean ± standard deviation (SD), and categorical variables were expressed as frequencies and percentages. Comparisons between groups (thyroid dysfunction vs. euthyroid PCOS women) were performed using the chi-square test for categorical variables and independent t-test or Mann-Whitney U test for continuous variables, depending on data normality. Correlation analyses were done using Pearson or Spearman correlation coefficients. A p-value < 0.05 was considered statistically significant. Data Collection Data were collected using a pre-designed case record form including demographic details, clinical history, examination findings, ultrasound results, and laboratory parameters. Fertility outcomes were documented from patient interviews and medical records. Data confidentiality and ethical standards were maintained throughout the study.

Table 1: Baseline Demographic and Clinical Characteristics of Women with PCOS (N = 200) Parameter Category / Mean (SD) n (%) or Mean (SD) Test Statistic (t/χ²) 95% Confidence Interval P-value Age (years) — 26.7 (5.8) t = 2.17 25.3 – 28.1 0.031* BMI (kg/m²) — 28.4 (4.6) t = 3.01 27.2 – 29.6 0.003* Duration of infertility (years) — 2.6 (1.9) t = 1.56 2.2 – 3.0 0.12 Menstrual irregularity Present 123 (61.5%) χ² = 21.5 — <0.001* Absent 77 (38.5%) Hirsutism (clinical) Present 82 (41.0%) χ² = 12.4 — <0.001* Absent 118 (59.0%) Thyroid dysfunction Present 64 (32.0%) χ² = 16.7 — <0.001* Absent 136 (68.0%) *Significant at p < 0.05 Table 1 presents the baseline demographic and clinical characteristics of 200 women diagnosed with Polycystic Ovary Syndrome (PCOS). The mean age of the participants was 26.7 years (SD ± 5.8), with a statistically significant variation (t = 2.17, p = 0.031). The average Body Mass Index (BMI) was 28.4 kg/m² (SD ± 4.6), which also showed significant differences (t = 3.01, p = 0.003). The duration of infertility among participants averaged 2.6 years (SD ± 1.9), though this was not statistically significant (t = 1.56, p = 0.12). Menstrual irregularity was reported in 61.5% (123/200) of women, demonstrating a highly significant association (χ² = 21.5, p < 0.001). Clinical hirsutism was present in 41.0% (82/200) of cases, also significant (χ² = 12.4, p < 0.001). Notably, thyroid dysfunction was observed in 32.0% (64/200) of women, a proportion significantly associated with PCOS characteristics (χ² = 16.7, p < 0.001). Table 2: Prevalence of Thyroid Dysfunction among Women with PCOS (N = 200) Thyroid Status n (%) Test Statistic (χ²) 95% Confidence Interval for Proportion P-value Euthyroid 136 (68.0%) — 61.2% – 74.2% — Hypothyroidism (Overt + Subclinical) 52 (26.0%) χ² = 14.8 20.2% – 32.7% <0.001* Hyperthyroidism 12 (6.0%) 3.0% – 10.0% 0.001* *Significant difference in prevalence of thyroid dysfunction types. Table 2 highlights the prevalence of thyroid dysfunction among women with PCOS. A majority of 68.0% (136/200) were euthyroid, with a 95% confidence interval ranging from 61.2% to 74.2%. Hypothyroidism, encompassing both overt and subclinical forms, was detected in 26.0% (52/200) of the participants, a statistically significant proportion compared to other thyroid statuses (χ² = 14.8, 95% CI 20.2% – 32.7%, p < 0.001). Hyperthyroidism was less common, affecting 6.0% (12/200) of the cohort, yet this prevalence was still significant (95% CI 3.0% – 10.0%, p = 0.001). Table 3: Impact of Thyroid Dysfunction on Menstrual Regularity and Ovulatory Status in Women with PCOS (N=200) Parameter Thyroid Dysfunction Present (n=64) Thyroid Dysfunction Absent (n=136) Test Statistic (χ²) / t 95% CI for Difference P-value Menstrual irregularity 52 (81.3%) 71 (52.2%) χ² = 18.4 — <0.001* Ovulatory dysfunction (confirmed by hormonal assay) 48 (75.0%) 73 (53.7%) χ² = 10.1 — 0.001* Mean serum LH (IU/L) 13.2 (4.9) 10.6 (3.7) t = 3.51 1.2 – 3.9 <0.001* Mean serum FSH (IU/L) 6.3 (2.0) 6.5 (1.8) t = 0.68 -0.6 – 0.3 0.50 *Statistically significant difference. Table 3 examines the impact of thyroid dysfunction on menstrual regularity and ovulatory status in women with PCOS. Among those with thyroid dysfunction (n=64), menstrual irregularity was reported in 81.3%, significantly higher than the 52.2% observed in euthyroid women (n=136) (χ² = 18.4, p < 0.001). Similarly, ovulatory dysfunction, confirmed by hormonal assays, was present in 75.0% of women with thyroid dysfunction compared to 53.7% in those without (χ² = 10.1, p = 0.001). The mean serum Luteinizing Hormone (LH) levels were significantly elevated in women with thyroid dysfunction (13.2 IU/L ± 4.9) compared to euthyroid participants (10.6 IU/L ± 3.7) (t = 3.51, 95% CI 1.2 – 3.9, p < 0.001). In contrast, serum Follicle Stimulating Hormone (FSH) levels did not differ significantly between groups (6.3 IU/L vs. 6.5 IU/L, t = 0.68, p = 0.50). Table 4: Association Between Thyroid Dysfunction and Fertility Outcomes in Women with PCOS (N=200) Fertility Outcome Thyroid Dysfunction Present (n=64) Thyroid Dysfunction Absent (n=136) Test Statistic (χ²) / t 95% CI for Difference P-value Conception rate (%) 15 (23.4%) 61 (44.9%) χ² = 9.57 — 0.002* Miscarriage rate (%) 8 (12.5%) 6 (4.4%) χ² = 5.12 — 0.024* Mean time to conception (months) 14.6 (5.7) 10.2 (3.9) t = 4.27 2.7 – 6.2 <0.001* *Significant association between thyroid dysfunction and poorer fertility outcomes. Table 4 analyzes the association between thyroid dysfunction and clinical fertility outcomes in women with PCOS. The conception rate was significantly lower in women with thyroid dysfunction (23.4%) than in euthyroid women (44.9%) (χ² = 9.57, p = 0.002). Miscarriage rates were notably higher among those with thyroid dysfunction at 12.5%, compared to 4.4% in the euthyroid group (χ² = 5.12, p = 0.024). Furthermore, the mean time to conception was prolonged in women with thyroid dysfunction, averaging 14.6 months (SD ± 5.7) versus 10.2 months (SD ± 3.9) for euthyroid women, a statistically significant difference (t = 4.27, 95% CI 2.7 – 6.2, p < 0.001). These findings underscore the negative impact of thyroid dysfunction on fertility outcomes in women with PCOS.

The present study evaluated the baseline demographic and clinical characteristics of 200 women with PCOS, with findings consistent with prior literature. The mean age of 26.7 years aligns closely with studies by Rotterdam consensus and others, which describe PCOS primarily affecting women of reproductive age, typically in their twenties and early thirties Romitti M et al.(2018)[6]. The observed mean BMI of 28.4 kg/m² indicates overweight status, reflecting the well-established link between PCOS and obesity or metabolic syndrome, as documented by Kirkegaard S et al.(2024)[7] who reported elevated BMI as a frequent comorbidity in PCOS patients. Menstrual irregularity was prevalent in 61.5% of participants, a finding comparable to studies by Mukherjee P et al.(2024)[8], where menstrual disturbances were reported in over 60% of PCOS women. Clinical hirsutism affected 41% of subjects, consistent with previous research highlighting hyperandrogenism as a hallmark feature of PCOS van der Ham K et al.(2023)[9]. The prevalence of thyroid dysfunction at 32% in this cohort is notable and corroborates evidence by Xu S et al.(2022)[10], who conducted a meta-analysis reporting a significant association between PCOS and increased risk of autoimmune thyroiditis and hypothyroidism. Table 2 highlights the prevalence of thyroid dysfunction, with hypothyroidism (overt and subclinical) affecting 26% of women. This figure parallels findings from He Y et al.(2019)[11], who identified a higher incidence of hypothyroidism among PCOS patients compared to the general population. The lower prevalence of hyperthyroidism (6%) is consistent with its comparatively rare occurrence in PCOS cohorts Cai J et al.(2019)[12]. The impact of thyroid dysfunction on menstrual regularity and ovulatory status (Table 3) is clinically significant. Women with thyroid dysfunction exhibited a markedly higher rate of menstrual irregularities (81.3%) compared to euthyroid women (52.2%), affirming findings by Ulrich J et al.(2018)[13] that thyroid hormone imbalances disrupt hypothalamic-pituitary-ovarian axis function, thereby impairing ovulation. Elevated serum LH levels in thyroid dysfunction cases (mean 13.2 IU/L) align with prior reports indicating altered gonadotropin secretion patterns in women with combined PCOS and thyroid disorders. The non-significant difference in FSH levels suggests selective dysregulation of LH in these patients. Table 4 demonstrates poorer fertility outcomes among women with thyroid dysfunction. The conception rate was significantly reduced (23.4% vs. 44.9%), and miscarriage rates were higher (12.5% vs. 4.4%) compared to euthyroid counterparts. These findings resonate with clinical studies by Bahreiny SS et al.(2024)[14] showing that thyroid dysfunction adversely affects implantation and pregnancy maintenance in PCOS. Additionally, prolonged time to conception in thyroid dysfunction groups further emphasizes the compounded reproductive challenge faced by this subgroup.

This cross-sectional study highlights a significant association between thyroid dysfunction and adverse fertility outcomes in women with Polycystic Ovary Syndrome (PCOS). Thyroid dysfunction, particularly hypothyroidism, was prevalent in nearly one-third of the study population and was linked to increased menstrual irregularity, higher rates of ovulatory dysfunction, reduced conception rates, elevated miscarriage rates, and prolonged time to conception. These findings emphasize the importance of routine thyroid function screening and timely management in women with PCOS to optimize reproductive health and improve fertility outcomes. Addressing thyroid abnormalities may represent a crucial component of holistic care in PCOS-related infertility. LIMITATIONS OF THE STUDY 1. Cross-Sectional Design: The study’s design limits the ability to establish causality between thyroid dysfunction and fertility outcomes; longitudinal studies are needed to assess temporal relationships. 2. Single-Center Study: Conducted at one tertiary care center, which may limit the generalizability of findings to broader populations. 3. Potential Selection Bias: Participants were women attending fertility clinics, which may overrepresent more severe PCOS cases or those actively seeking fertility treatment. 4. Limited Thyroid Parameters: The study primarily assessed TSH, FT3, and FT4; inclusion of thyroid autoantibodies (e.g., anti-TPO) could provide deeper insights into autoimmune thyroid disorders’ role. 5. Self-Reported Fertility Outcomes: Some fertility data were based on patient recall, which may be subject to reporting bias. 6. Unmeasured Confounders: Factors such as lifestyle, diet, insulin resistance, and other metabolic parameters were not extensively analyzed, which might influence fertility and thyroid status.

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