Evidence map›Paper›PMID 37464435›Full record

ArticleTrials2023

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.

Neena Malhotra, Taruna Arora, Vanita Suri, Saubhagya Kumar Jena, Asha Verma, Mahasampath Gowri, Nitin Kapoor, Manjeet Singh Chalga, Bharati Kulkarni, Mohan S Kamath

Erratum issuedOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 7 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 2 countries.

Neena MalhotraDivision of Reproductive Medicine, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.
Taruna AroraDivision of Reproductive and Child Health and Nutrition, Indian Council of Medical Research, New Delhi, India.
Vanita SuriDepartment of Obstetrics and Gynaecology, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.
Saubhagya Kumar JenaDepartment of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
Asha VermaDepartment of Obstetrics and Gynaecology, Sawai Man Singh Medical College, Jaipur, Rajasthan, India.
Mahasampath GowriDepartment of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India.
Nitin KapoorDepartment of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, India.
Manjeet Singh ChalgaDivision of Biomedical Informatics, Indian Council of Medical Research, New Delhi, India.
Bharati KulkarniDivision of Reproductive and Child Health and Nutrition, Indian Council of Medical Research, New Delhi, India.
Mohan S KamathDepartment of Reproductive Medicine and Surgery, Christian Medical College, Vellore, Tamil Nadu, India. mohankamath@cmcvellore.ac.in.
Indian Council of Medical Research · INChristian Medical College & Hospital · INAll India Institute of Medical Sciences · INAll India Institute of Medical Sciences Bhubaneswar · INBaker Heart and Diabetes Institute · AUPost Graduate Institute of Medical Education and Research · INSawai ManSingh Medical College and Hospital · IN

Funding

Indian Council of Medical Research 5/10/NTF/FR/32/2022-RBMCH
6 · The paper itself

Abstract

backgroundPolycystic 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.

methodsThe 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 years 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 ≥ 23 and ≤ 35 kg/m DISCUSSION: The IPOS trial results could help clarify and provide more robust evidence for advocating an individualized lifestyle intervention in PCOS women who wish to conceive.

trial registrationClinical Trial Registry of India CTRI/2023/04/051620. Registered on 13 April 2023.

Indexed as

Infertility, FemalePolycystic Ovary SyndromeAdultFemaleHumansLife StyleObesityPregnancyQuality of LifeRandomized Controlled Trials as TopicYoung Adult

Identifiers

PMID37464435
PMCPMC10353229
OpenAlexW4384663681

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.