Normative range of various serum hormonal parameters among Indian women of reproductive age: ICMR-PCOS task force study outcome.

Mohd Ashraf Ganie ,Roya Rozati,Wahid Ali Khan ,Awadhesh Kumar Singh ,Rabiya Rashid ,Mudasir S Makhdoomi ,Mousumi Mukhopadhyay ,Shaik Iqbal Ahmed ,Prasanta Bhattacharya ,Eli Mohapatra ,Humaira Minhaj ,Gourisankar Kamilya ,Shariq Rashid Masoodi ,Malathi Ponnuru ,Hemangini Thakkar ,L N Rao ,Tabassum Parvez ,Manish Agrawal ,Ashok Anand ,Aashima Arora ,Najeeb Ur Rehman ,Imtiyaz Ahmad Wani ,Rajesh Sagar ,Narendra Kuber Bodhey ,Bharati Kulkarni ,R Harish ,Rama Walia ,Devasenathipathy Kandasamy ,Narayanasamy Ravi ,Amlin Shukla ,Bharti Kulkarni ,Dibakar Sahu ,Neeta Kumar ,Parvaiz A Koul ,Sandeep Chandrakar ,Anuja Elizabeth George ,Nadeem Ahmad ,Puthiyaveettil Khadar Jabbar ,Jai Bhagwan Sharma ,Subhodip Pramanik ,Himali Vadhan ,Mukesh Srivastava ,Sultan Rizwan Ahmed ,Babu Ram ,Gazala Hasan ,Nidhi Gupta ,Sudipta Banerjee ,Abilash Nair ,Donboklang Lynser ,Saba Noor ,Ajay M V Kumar ,Sarita Agrawal ,Gaivee Vinam Meshram ,Rita Parab ,Aruna Ramaiah ,Lokesh Kumar Singh ,Seema Qayoom ,Shahina Begum ,Rani Sujatha ,Haroon Rashid ,Jayasree Leelamma ,Shazia Rashid ,Shyam Prakash ,Gaurav Thakur ,Pradip Mukhopadhyay ,Ghulam Nabi Yatoo ,Vanita Suri ,Nantu Sarkar ,Vishnubhatla Sreenivas ,Saikat Mukherjee ,Dipankar De ,Tariq Gojwari ,Tulika Singh ,Nitin Deshpande ,Ishfaq Ahmad Shah ,Anushree Patil ,Jessy Abraham ,Sudha Bindu ,Neena Malhotra ,Nitish Naik ,Aleem Ahmed Khan ,Subhankar Chowdhury ,Sanghamitra Pati ,Alice Abraham Ruram ,Sabah Siddiqui ,Balaji Bhasker ,Wasia Showkat ,Neena Khanna ,Pieu Adhikary ,Zafar A Shah ,Jayakumari ,Rakesh Sahay ,Nirmala Chongtham ,Naseer Ahmed ,Beena Joshi ,Prabhakar Rao ,Taruna Arora ,Muzafar M Wani ,Shaikh Sharmeen ,Mudasir Fayaz ,Rohina Bashir ,A Suresh

doi:10.1016/j.lansea.2023.100226

Abstract

The hormonal profile varies considerably with age, gender, ethnicity, diet or physiological state of an individual. Limited population-specific studies have studied the variations in hormonal parameters among apparently healthy women. We aimed to analyse the biological reference interval for various hormonal parameters in the reproductive-aged healthy Indian women. Out of 3877 participants that were clinically evaluated, 1441 subjects were subjected to laboratory investigations. All participants underwent a detailed clinical, biochemical and hormonal profiling. The hormone analysis was carried out at a single centre using a uniform methodology. Among the participants evaluated for biochemical and hormonal parameters, subjects that presented any abnormal profile or had incomplete investigations (n=593) were excluded for further analysis. The mean age (±SD) of the subjects retained in the final analysis (n=848) was 29.9 (±6.3) years. In the present study, the biological reference interval (2.5th-97.5th centile) observed were: serum T4: μg/dL (5.23-12.31), TSH: μg/mL (0.52-4.16) and serum prolactin: ng/mL (5.13-37.35), LH: mIU/mL (2.75-20.68), FSH: mIU/mL 2.59-15.12), serum total testosterone: ng/mL (0.06-0.68), fasting insulin: mIU/mL (1.92-39.72), morning cortisol: μg/dL (4.71-19.64), DHEAS:μg/dL (50.61-342.6) and SHBG: nmol/L (21.37-117.54). Unlike T4, TSH, LH, and E2, the biological reference interval for prolactin, FSH, testosterone, C-peptide insulin and DHEAS varied when the subjects were stratified by age (p<0.05). The comparative analysis showed marginal differences in the normative ranges for the hormones analysed among different populations. Our first large composite data on hormonal measures will benefit future endeavours to define biological reference intervals in reproductive-aged Indian women. The study was financially supported by the grant-in-aid from ICMR vide file No:5/7/13337/2015-RBMH.

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