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
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Abstract Background 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. Methods The 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/m2 and duration of infertility ≤ 3 years. We plan to randomize women with PCOS into two groups: group A will receive the intervention which will consist of individualized advice on diet and physical exercise along with a telephonic reminder system and follow-up visits, and group B (control) will receive one-time advice on diet and physical exercise. Both groups will receive up to three cycles of ovulation induction with letrozole after 3 months of randomization during the 6-month treatment period. The primary outcome of the trial will be the live birth following conception during the intervention period. The secondary outcomes include clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate, ectopic pregnancy rate, stillbirth, time to pregnancy, mean weight loss, differences in anthropometric parameters, improvement in menstrual regularity and quality of life score. 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 registration Clinical Trial Registry of India CTRI/2023/04/051620. Registered on 13 April 2023.
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One phone-based study is a protocol published in 2023 from India regarding a multicenter trial to evaluate effectiveness of an individualized lifestyle intervention for women with PCOS trying to conceive.
“One of the studies is a protocol published in 2023 from India regarding a multicenter trial to evaluate the effectiveness of an individualized lifestyle intervention for women with PCOS who are trying to conceive [96].”
From Polycystic Ovary Syndrome and the Internet of Things: A Scoping Review (2024) · cites this paper as [96]
In five of the phone-based publications, either text messages providing feedback to patients or both text messages and phone calls with patients are mentioned.
“In five of them, either text messages providing feedback to the patients [48,49,50,51], or both text messages and phone calls with the patients are mentioned [96].”
From Polycystic Ovary Syndrome and the Internet of Things: A Scoping Review (2024) · cites this paper as [96]
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Polycystic Ovary Syndrome and the Internet of Things: A Scoping Review
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- Authors
- Malhotra, N., Arora, T., Suri, V., Jena, S. K., Verma, A., Gowri, M., Kapoor, N., Chalga, M. S., Kulkarni, B., & Kamath, M. S.
- Affiliations
- All India Institute of Medical Sciences (IN)
- Indian Council of Medical Research (IN)
- Post Graduate Institute of Medical Education and Research (IN)
- All India Institute of Medical Sciences Bhubaneswar (IN)
- SMS Medical College (IN)
- Christian Medical College, Vellore (IN)
- Baker Heart and Diabetes Institute (AU)
- Corresponding author
- Kamath, Mohan S.
- ORCID
- Venue
- Trials
- Published
- 2023-07-18
- Volume
- 24
- Issue
- 1
- Pages
- 457-457
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC10353229
- OpenAlex
- W4384663681
- Cited by
- 10
- References
- 33
- Citations by year
- 2026: 4 · 2025: 1 · 2024: 3 · 2023: 2
- FWCI
- 2.40
- Type
- journal article
- Language
- en
- Update notices
- correction (2023-07-31)
- Open access
- gold
- dx.doi.org
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Indian Council of Medical Research (5/10/NTF/FR/32/2022-RBMCH)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Reproductive Medicine › Reproductive Health and Technologies
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Keywords
- polycystic ovary syndrome, infertility, fertility preservation, dietary recommendations, physical activity, live birth, South Asian women, insulin resistance, weight loss, menstrual cycle regularity, quality of life
- MeSH terms
- Adult, Female, Humans, Infertility, Female, Life Style, Obesity, Polycystic Ovary Syndrome, Pregnancy, Quality of Life, Randomized Controlled Trials as Topic, Young Adult
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