{
    "abstract": "Polycystic ovary syndrome (PCOS) is a common endocrine condition which affects women in the reproductive age group. South Asian women with PCOS have a higher risk of insulin resistance and metabolic disorder compared to women from other ethnic backgrounds. Lifestyle interventions such as dietary advice and physical exercise are recommended as a first-line management option for infertile women with PCOS. Most of the randomized controlled trials evaluating the role of lifestyle interventions in infertile PCOS women were characterized by methodological issues. The uptake of lifestyle modifications as a treatment strategy in the South Asian population is complicated by a difficult-to-change conventional high-carbohydrate diet and limited availability of space for physical activity in the region.\nThe study is designed as an open-label, multicentre, randomized controlled trial in South Asian women with PCOS. Women attending the fertility clinic will be screened for eligibility, and women aged between 19 and 37\u00a0years who have been diagnosed with PCOS and wishing to conceive will be invited to participate in the trial. We will include women with body mass index (BMI) between\u2009\u2265\u200923 and\u2009\u2264\u200935\u00a0kg/m\nThe IPOS trial results could help clarify and provide more robust evidence for advocating an individualized lifestyle intervention in PCOS women who wish to conceive.\nClinical Trial Registry of India CTRI/2023/04/051620. Registered on 13 April 2023.",
    "authors": [
        {
            "affiliation": "Division of Reproductive Medicine, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.",
            "firstname": "Neena",
            "initials": "N",
            "lastname": "Malhotra"
        },
        {
            "affiliation": "Division of Reproductive and Child Health and Nutrition, Indian Council of Medical Research, New Delhi, India.",
            "firstname": "Taruna",
            "initials": "T",
            "lastname": "Arora"
        },
        {
            "affiliation": "Department of Obstetrics and Gynaecology, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.",
            "firstname": "Vanita",
            "initials": "V",
            "lastname": "Suri"
        },
        {
            "affiliation": "Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.",
            "firstname": "Saubhagya Kumar",
            "initials": "SK",
            "lastname": "Jena"
        },
        {
            "affiliation": "Department of Obstetrics and Gynaecology, Sawai Man Singh Medical College, Jaipur, Rajasthan, India.",
            "firstname": "Asha",
            "initials": "A",
            "lastname": "Verma"
        },
        {
            "affiliation": "Department of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India.",
            "firstname": "Mahasampath",
            "initials": "M",
            "lastname": "Gowri"
        },
        {
            "affiliation": "Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, India.\nNon-Communicable Disease Unit, Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.",
            "firstname": "Nitin",
            "initials": "N",
            "lastname": "Kapoor"
        },
        {
            "affiliation": "Division of Biomedical Informatics, Indian Council of Medical Research, New Delhi, India.",
            "firstname": "Manjeet Singh",
            "initials": "MS",
            "lastname": "Chalga"
        },
        {
            "affiliation": "Division of Reproductive and Child Health and Nutrition, Indian Council of Medical Research, New Delhi, India.",
            "firstname": "Bharati",
            "initials": "B",
            "lastname": "Kulkarni"
        },
        {
            "affiliation": "Department of Reproductive Medicine and Surgery, Christian Medical College, Vellore, Tamil Nadu, India. mohankamath@cmcvellore.ac.in.",
            "firstname": "Mohan S",
            "initials": "MS",
            "lastname": "Kamath"
        }
    ],
    "conclusions": null,
    "copyrights": "\u00a9 2023. The Author(s).",
    "doi": "10.1186/s13063-023-07466-y\n10.1093/humrep/deh098\n10.1093/humrep/deaa371\n10.1111/cen.12784\n10.1111/jog.14132\n10.1016/j.fertnstert.2008.06.035\n10.1093/humupd/dms019\n10.1016/j.bpobgyn.2004.05.001\n10.1093/humupd/dmn015\n10.1093/humrep/dey256\n10.1210/jc.2015-2778\n10.1210/jc.2008-0751\n10.1093/humrep/dem391\n10.1111/cen.14452\n10.1016/j.ejogrb.2018.12.021\n10.2147/DMSO.S278928\n10.1017/S1368980020003432\n10.7326/0003-4819-158-3-201302050-00583\n10.1177/2055102918788195\n10.1016/j.fertnstert.2020.11.013\n10.1016/j.fertnstert.2017.06.005\n10.1111/jog.14926\n10.1093/humrep/det026\n10.1079/BJN19970114\n10.1093/fampra/cml066\n10.1371/journal.pone.0237974\n10.1016/j.clinthera.2020.06.007\n10.1136/bmj.l5342",
    "journal": "Trials",
    "keywords": [],
    "methods": null,
    "publication_date": "2023-07-19",
    "pubmed_id": "37464435\n14688154\n33501984\n25824095\n31588677\n18950759\n22611175\n15380140\n18499708\n30052961\n30921477\n26401593\n32969197\n18583464\n18158291\n33638879\n30690191\n33889005\n33000718\n23295957\n36507649\n30038788\n33272619\n28760517\n34355476\n23427235\n9292755\n17179137\n32841271\n32718783\n31597627",
    "results": null,
    "title": "Individualized lifestyle intervention in PCOS women (IPOS): a study protocol for a multicentric randomized controlled trial for evaluating the effectiveness of an individualized lifestyle intervention in PCOS women who wish to conceive.",
    "xml": "<Element 'PubmedArticle' at 0x7885038f27a0>"
}