A prospective comparative case-control study carried out at Department of Biochemistry, Grant Government Medical College and Sir JJ Group of Government Hospitals, Mumbai, India. All participants completed a medical history form and provided informed consent. A total of 30 study cases of PCOS with mean age was 29.7±5.51 years, who attended to the gynaecology OPD were studied for estimation of serum CA-125, LH, FSH and PRL over a period of eight months from July 2010 to March 2011. Age-matched 30 subjects were taken as controls. The Institutional Ethical Committee (vide approval letter No. GMC/Pharm/610/2010, dated-15/07/2010) at the Grant Medical College and Sir J. J. Group of Government Hospitals, Mumbai, approved the study.

A necessary criterion for recruitment amongst all the women was complete absence of any form of pituitary, thyroid, or adrenal disorder, as well as any form of hormonal treatment before the study. Study cases who were already diagnosed with PCOS by clinician-the criteria were the recruitment of women in the reproductive age group, with varying degrees of oligomenorrhoea and chronic anovulation. Presence of polycystic ovaries as a common underlying feature in these women with infertility was confirmed through detection by transvaginal ultrasonography by the clinician. The healthy subjects of non-hirsute, non-obese women with regular menstrual cycles came for the general checkup in the Sir JJ Hospital, Mumbai were included as control.

Five millilitres fasting venous blood samples were drawn from an antecubital vein of the included women in red coloured coded plain vacutainers. Blood samples were allowed to be clotted for 30 minutes then centrifuged for 15 minutes at 3000 rpm and sera used for the biochemical analysis. We used fully automated enzyme amplified chemiluminescent immunoassay analyser model Immulite 1000 for measurement of CA-125, LH, FSH and PRL. The principle of method is based on a solid-phase, two-site chemiluminescent immunometric assay [10,11]. Measurement of these blood parameters was done by using commercial kits from Siemens Medical Solutions Diagnostics, Los Angeles, CA, USA.

The date entry and data analysis were done using the Statistical Package for the Social Sciences (SPSS) version 19.0. Data were presented as number, percentage, mean and standard deviation. Statistical analysis was done by normal distribution ‘z’ test. The p-values were considered statistically significant and highly significant when p<0.05 and p<0.001 respectively.

In the present study, 30 patients with PCOS, mean age 29.7 years (±5.51) and 30 controls, mean age 30.8 years (±4.65) were included.

There were insignificant differences in the mean levels of age of the study cases however, significant difference found in mean levels of haemoglobin (Hb) and BMI among patients versus controls (p<0.05 and p<0.001 respectively), which were all within the normal range to confirm the inclusion criteria as presented in [Table/Fig-1].

Comparison of the mean±SD of CA-125, LH, FSH and PRL among patients versus controls is presented in [Table/Fig-2], which showed significantly higher (p<0.001) serum CA-125 levels with insignificantly lower serum levels of FSH among patients versus controls. Serum levels of LH and PRL were significantly elevated in the PCOS cases with controls.

Polycystic ovarian syndrome is a herald of lifelong conditions that can lead to serious sequelae such as endometrial or ovarian cancer, diabetes mellitus and cardiovascular disease [12]. Demographic data of study subjects such as age was statistically insignificant, mean Hb level significantly change (p<0.05) whereas BMI was highly significant as compared with those of control group in patients.

The present study showed highly significant (p<0.001) i.e., seven times increase in serum CA-125 levels in subjects with PCOS as compared to that of control group. In the present study, it is not possible to understand the meaning of an abnormally high CA-125 without supplementary information about the particular patient being evaluated. The cause is that blood levels of this tumour marker can be elevated in many different benign and malignant conditions. Even though CA-125 is a helpful investigation in examining patients who are being treated for ovarian cancer [13], however, a single CA-125 test is not considered to be a useful screening test for cancer reported by Magrina JF and Cornella JL [14].

Serum levels of LH were elevated significantly (p<0.05) in the group of patients with PCOS. Similar to present results Lobo RA et al., also observed increased serum LH levels [15]. On the contrary, serum FSH levels were reduced insignificantly as compared to those of controls. Serum FSH concentration usually normal or low found in PCOS patients [16]. One probable clarification for this observation may be a speed up Gonadotropin Releasing Hormone (GnRH) pulse generator activity and heightened pituitary response to GnRH. Because the synthesis and secretion of LH and FSH are highly dependent on the pattern of GnRH stimulation [15,16].

Authors observed statistically significant increase (p<0.05) in serum PRL levels in PCOS subjects as compared to that of the control group which might be a result of a defect in hypothalamic dopaminergic activity [17]. Kyritsi EM et al., identified a serum PRL cut-off value indicative of a PRL producing adenoma in women with PCOS and hyperprolactinemia and characterised such patients. They found, in women with PCOS, PRL levels exceeding 85.2 ng/mL are highly suggestive of a prolactinoma justified pituitary imaging [18]. No single subject with prolactinemia found in present study.

Patients with PCOS have a 2.7-fold increased risk for developing endometrial cancer. A major factor for this increased malignancy risk is prolonged exposure of the endometrium to unopposed estrogen that results from anovulation. Additionally, secretory endometrium of some women with PCOS undergoing ovulation induction or receiving exogenous progestin exhibits progesterone resistance accompanied by dysregulation of gene expression controlling steroid action and cell proliferation, reported by Dumesic DA and Lobo RA [19]. Fearnley EJ et al., suggested PCOS is a risk factor for endometrial cancer [20].

Barry JA et al., examined gynaecological malignancies in women with PCOS and their systemic review and meta-analysis data suggested that women of all ages with PCOS are at higher risk of endometrial cancer but the risk of ovarian and breast cancer was not significantly increased overall [21]. The precise possibility of ovarian malignancy in patients with PCOS is difficult to conclude.

The present study was a short-term project, has been limited to a comparatively small number of cases of ovarian cancer identified specifically in PCOS. However, the limitation of present study was small sample size; so, more studies with good sample size are required to corroborate these results.

The present findings suggest that increased levels of CA-125, LH, PRL and low levels of FSH may be an indicator of ovarian abnormalities in PCOS. Authors therefore, suggest that these investigations should be performed routinely in women having PCOS. This will definitely aid in the management of PCOS which would otherwise lead to life-threatening conditions such as ovarian cancer or endometrial cancer. Further prospective and controlled studies are required to investigate the power and reliability of tumour markers and endocrine hormones in the early diagnosis of ovarian or endometrial tumours.