Analysis of Hormonal Biomarkers in Menstrual Blood of Adult Female with Polycystic Ovarian Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- clinical reference value of hormones in the menstrual blood of healthy adults
研究概览
简要总结
Infertility/Subfertility is a complex disorder associated with significant medical, psychosocial, and economic aspects. Hormonal imbalance is a serious medical health issue with the potential to lead to various other diseases such as infertility, PCOS, ovarian irregularity, hyperandrogenism, cystic ovaries, higher insulin levels, and type 2 diabetes. The prevalence of PCOS in Indian adolescents is around 12.2% according to the Indian Council of Medical Research. An underdiagnosed or over-diagnosed PCOS condition will put the woman at a high risk of serious complications, cause an intake of unnecessary medications, and huge psychological impact. People with regular menstrual cycles and healthy or lower BMI can also develop PCOS. If these conditions are untreated at the right time, it may lead to several comorbidities like diabetes, heart disease, etc. Hormonal such as gonadotropin-releasing hormone (GnRH), insulin, the luteinizing/ follicle-stimulating hormone (LH/FSH) ratio, androgens, estrogens, growth hormones (GH), cortisol, parathyroid hormone (PTH), and calcitonin are disturbed and are used as biomarkers to identify issues related to PCOS. The presence of these biomarkers apart from venous blood is less explored. The present study is designed to explore the presence of hormone biomarkers in menstrual blood correlating to the venous blood in PCOD/PCOS conditions. The aim of the study is to find the presence and quantify the hormonal biomarkers in menstrual blood (non-invasive samples) in PCOD patients. An observational study design is developed with two groups PCOD/PCOS positive group and control group. Venous blood and menstrual blood will be collected and analyzed for the hormone biomarkers using the CLIA method. Statistical analysis involving the relationship and correlation of the hormone biomarkers in the participants will be evaluated and interpreted. Thus analysing these hormone biomarkers will help predict the menstrual health that would allow PCOD/PCOS women and the clinicians to make more precise predictions about the nature and timing of their abnormality and proceed with the early treatment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- Female
入选标准
- •Inclusion criteria for cases
- •Women aged between
- •Women with irregular menstrual cycles
- •Women with PCOD
- •Menorrhoea.
排除标准
- •Exclusion criteria for controls
- •Pregnant women
- •Women with a history of miscarriage or abortion
- •Lactating mothers
- •Women with any history of congenital abnormalities of the genito-urinary system
- •Women with Vaginal candidiasis, any infectious or fungal disease
- •Women with uterine fibroids
- •Women who have undergone hysterectomy Exclusion criteria for cases
- •Menopausal women
- •Women undergoing hormonal replacement therapy
- •Women with uterine fibroids
- •Women who have undergone hysterectomy.
结局指标
主要结局
clinical reference value of hormones in the menstrual blood of healthy adults
时间窗: 8 Months
次要结局
- 1. Hormone levels in menstrual blood(2. Comparison or ratio of hormone levels between menstrual & venous bloods)
研究者
Dr Kalaiarasi S
Thremear Pvt Ltd
