Effects Of Non-invasive Intervention in Oligomenorrhea and Infertility in Poly Cystic Ovary Syndrome Women of Reproductive Age
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- fertility hormone
研究概览
简要总结
Procedure: Women diagnosed with Polycystic Ovary Syndrome will be assessed using a screening performa. Women who met the inclusion criteria and gave their consent to participate in the study protocol will be recruited. Women will then be randomly assigned to the four groups using computerized randomization technique.
Pre and post assessment will be performed for the following variables.
Menstrual Regularity: Assessed at baseline and at post-treatment follow-up. Participants will self-monitor their menstrual cycles using a standardized menstrual diary throughout the study period. Regularity will be defined as cycles occurring every 21–35 days over at least two consecutive months.
Menstrual Pain: Measured using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).VAS scores will be recorded pre-intervention and post-intervention. Menstrual regularity: will measure at initial presentation and post treatment follow up. Menstrual cycle will self-monitored by subjects using a standardized menstrual diary.
Body Mass Index (BMI): BMI is calculated as: the ratio of body weight in kilograms to the square of the height in meters where in height will measure to 0.5cm using calibrated stadiometer and body weight will measure using calibrated clinical scale to the nearest 0.01 kg. Measurements will be taken with participants wearing light clothing and no shoes.
Fertility Parameters: Anti-Müllerian Hormone (AMH) levels will be used as a marker of ovarian reserve. Blood samples for AMH testing will be collected pre- and post-intervention under standardized conditions.
Quality of life: Evaluated using standardized tools: Depression, Anxiety and Stress Scale – 21 (DASS-21), Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ).
| Experimental groupA |
Office going/sitting job
Control group B
Office going /sitting job
Experimental group C
Home maker
Control group D
homemaker
|Core strengthening ex
Cat and camel(5+5repetion with 30 second hold ,10 minutes)
Medical management
Core strengthening ex
Cat and camel(5+5repetion with 30 second hold ,10 minutes)
Medical management
|Relaxation ex
Contract and relax selected group of muscles Jacobson technique 10 minutes,deep breathing ex
Relaxation ex
Contract and relax selected group of muscles Jacobson technique 10 minutes,deep breathing ex
|Aerobic ex
20 minutes on treadmill with 5mph speed with 10%grade
Aerobic ex
20 minutes on treadmill with 5mph speed with 10%grade
|Visceral manipulation
Uterus mobilisation for 10 minutes
Visceral manipulation
Uterus mobilisation for 10 minutes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •Diagnosis of PCOS with a history of attempting to conceive for more than a year Presence of irregular or painful periods.
排除标准
- •Hypertension, Diabetes or any other chronic Disease Neurological or Cardiovascular disorders.
结局指标
主要结局
fertility hormone
时间窗: BEFORE GIVING THE INTERVENTION AND AFTER 12 WEEKS OF INTERVENTION
pain
时间窗: BEFORE GIVING THE INTERVENTION AND AFTER 12 WEEKS OF INTERVENTION
menstural regularity
时间窗: BEFORE GIVING THE INTERVENTION AND AFTER 12 WEEKS OF INTERVENTION
Body Mass Index
时间窗: BEFORE GIVING THE INTERVENTION AND AFTER 12 WEEKS OF INTERVENTION
Quality of life
时间窗: BEFORE GIVING THE INTERVENTION AND AFTER 12 WEEKS OF INTERVENTION
次要结局
未报告次要终点
研究者
Saleha Khan
G.D.Goenka University
