Integrative Multiomics Study Of Uterine Fibroid Pathogenesis among Indian Women at Tertiary Health Care Centre (Ahmedabad)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Defining the relationship between the risk factors (Vitamin D, estrogen, and metabolic syndrome) of uterine fibroids with bile acids.
研究概览
简要总结
Uterine fibroids are a common condition affecting a staggering 60% of reproductive-age women globally. While these mostly benign growths may not cause any symptoms, 25% of patients may experience debilitating morbidities, including heavy menstrual bleeding, pelvic pressure, urinary symptoms, infertility, and pregnancy complications .Unfortunately, currently available hormone-based therapies provide only temporary relief and frequently trigger undesirable side effects, with hysterectomy often remaining the only solution for lasting relief. This places a considerable economic burden on patients and healthcare systems, making it crucial to uncover novel molecular targets or pathways that may help in early detection and prognosis of uterine fibroids and develop novel therapy. To achieve this, our study aims to investigate the bile acid levels in the blood samples of women as well as the gut microbiota of women with uterine fibroids to those of age and BMI-matched non-fibroid women and then analyze the transcriptome of uterine smooth muscle cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age and BMI-matched premenopausal women of 25-50 years of age from tertiary health care center in Ahmedabad, with different gynecological complaints.
- •All of them will receive an ultrasound scan.
- •Among them, women with at least one fibroid (mean volume of ≥ 2 cm3) will be recruited.
- •We will also recruit women who are willing to/undergoing hysterectomy surgery.
- •The rest of the patients who will have normal ultrasonography scans will be recruited as controls (i.e., non-fibroid patients).
排除标准
- •Women with Polycystic ovary syndrome, Endometriosis, Adenomyosis, pregnancy or pregnancy within the last 6 months.
- •Currently breastfeeding or breastfeeding within the last 6 months; history of acute or chronic neoplasm; history of smoking and alcohol consumption.
- •Hormonal treatment, including oral contraceptives and antibiotics, within the last 1 month.
结局指标
主要结局
Defining the relationship between the risk factors (Vitamin D, estrogen, and metabolic syndrome) of uterine fibroids with bile acids.
时间窗: 1 Year
Insight into the gene expression profiles of uterine smooth muscle cells, and revealing any positive association with bile acid.
时间窗: 1 Year
Insight into alterations in gut microbiota and its association with bile acid homeostasis in uterine fibroid patients
时间窗: 1 Year
次要结局
- Uncovering novel molecular targets or pathways that may help in early detection and(prognosis of uterine fibroids.)
研究者
Sneha Mohan Nair
Gujarat Technological University School of Pharmacy