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临床试验/CTRI/2025/10/095908
CTRI/2025/10/095908尚未招募4 期

Effects Of Non-invasive Intervention in Oligomenorrhea and Infertility in Poly Cystic Ovary Syndrome Women of Reproductive Age

Saleha Khan1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月4日最近更新:

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

发起方
Saleha Khan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Saleha Khan

G.D.Goenka University

研究点 (1)

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