Division of Reproductive Medicine, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.
Division of Reproductive and Child Health and Nutrition, Indian Council of Medical Research, New Delhi, India.
Trials. 2023 Jul 18;24(1):457. doi: 10.1186/s13063-023-07466-y.
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.
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/m 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.
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.
Clinical Trial Registry of India CTRI/2023/04/051620. Registered on 13 April 2023.
多囊卵巢综合征（PCOS）是一种常见的内分泌疾病，影响育龄妇女。与其他族裔背景的妇女相比，南亚的 PCOS 妇女患胰岛素抵抗和代谢紊乱的风险更高。饮食建议和体育锻炼等生活方式干预被推荐为 PCOS 不孕妇女的一线治疗选择。评估生活方式干预对不孕 PCOS 妇女作用的大多数随机对照试验都存在方法学问题。由于该地区难以改变的传统高碳水化合物饮食和有限的体育活动空间，南亚人群对生活方式改变作为治疗策略的接受程度较为复杂。
本研究是在南亚 PCOS 妇女中进行的开放性、多中心、随机对照试验。将对生育诊所的就诊妇女进行筛选，符合条件的 19 至 37 岁诊断为 PCOS 且希望怀孕的妇女将被邀请参加试验。我们将纳入 BMI 介于 23 至 35kg/m2 之间且不孕持续时间≤3 年的妇女。我们计划将 PCOS 妇女随机分为两组：A 组将接受干预，包括饮食和体育锻炼的个体化建议以及电话提醒系统和随访，B 组（对照组）将接受一次关于饮食和体育锻炼的建议。两组在随机分组后 3 个月的 6 个月治疗期间，将接受多达 3 个周期的来曲唑促排卵。试验的主要结局是干预期间受孕后的活产。次要结局包括临床妊娠率、持续妊娠率、流产率、宫外孕率、死胎、妊娠时间、平均体重减轻、人体测量参数差异、月经规律和生活质量评分改善。
IPOS 试验结果可能有助于澄清并为提倡在希望怀孕的 PCOS 妇女中进行个体化生活方式干预提供更有力的证据。
印度临床试验注册处 CTRI/2023/04/051620。于 2023 年 4 月 13 日注册。
