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CTRI Number  CTRI/2025/10/095908 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Improving Irregular Periods and Fertility in Women with Polycystic Ovary Syndrome Using Non -Invasive Techniques 
Scientific Title of Study   Effects Of Non-invasive Intervention in Oligomenorrhea and Infertility in Poly Cystic Ovary Syndrome Women of Reproductive Age 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saleha Khan 
Designation  PhD Scholar 
Affiliation  G.D.Goenka University 
Address  Department of Physiotherapy,School of Healthcare and Allied sciences G.D.Goenka University,Sohna,Gurugram

Gurgaon
HARYANA
122103
India 
Phone  9873897342  
Fax    
Email  220100601001.saleha@gdgu.org  
 
Details of Contact Person
Scientific Query
 
Name  Tabish Fahim 
Designation  Associate professor 
Affiliation  G.D.Goenka University 
Address  Department of Physiotherapy,School of Healthcare and Allied sciences

Gurgaon
HARYANA
122103
India 
Phone  9718481337  
Fax    
Email  tabish.fahim@gdgu.org  
 
Details of Contact Person
Public Query
 
Name  Tabish Fahim 
Designation  Associate professor 
Affiliation  G.D.Goenka University 
Address  Department of Physiotherapy,School of Healthcare and Allied sciences

Gurgaon
HARYANA
122103
India 
Phone  9718481337  
Fax    
Email  tabish.fahim@gdgu.org  
 
Source of Monetary or Material Support  
Department of Physiotherapy,School of Healthcare and Allied sciences G.D.Goenka University,Sohna,Gurugram 122103 Haryana,India 
 
Primary Sponsor  
Name  Saleha Khan 
Address  Department of Physiotherapy,School of Healthcare and Allied sciences G.D.Goenka University,Sohna,Gurugram,122103,Haryana,India 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrTabish Fahim  Laadlee Gynae and Ferility Clinic  Above Apollo Pharmacy Sector 110 Noida
Gautam Buddha Nagar
UTTAR PRADESH 
09718481337

tabish.fahim@gdgu.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Waves Women Empowerment Trust   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Medical treatment  office working females/Housewives age 18-35 
Intervention  Relaxation exercise Aerobic training core strengtehing exercise visceral manipulation  office workin females/Housewives age 18-35 two times in a week for 12 weeks approx 1 hour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Diagnosis of PCOS with a history of attempting to conceive for more than a year
Presence of irregular or painful periods 
 
ExclusionCriteria 
Details  Hypertension, Diabetes or any other chronic Disease
Neurological or Cardiovascular disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
fertility hormone
pain
menstural regularity
Body Mass Index
Quality of life 
BEFORE GIVING THE INTERVENTION AND AFTER 12 WEEKS OF INTERVENTION 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   04/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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

 

 

 

 

 

 


 
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