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CTRI Number  CTRI/2020/02/023320 [Registered on: 13/02/2020] Trial Registered Prospectively
Last Modified On: 10/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Effect of Polycystic ovarian syndrome(PCOS) on female egg and its surrounding environment 
Scientific Title of Study   Impact of polycystic ovary syndrome (PCOS) on epigenetic integrity of granulosa cells and ultrastructure of oocytes  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali S 
Designation  Student 
Affiliation  Kasturba Medical College, Manipal 
Address  Deparment of Clinical Embryology, Central Research Lab, Near MIS office, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9746195944  
Fax    
Email  anjali.s4@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shubashree Uppangala 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Deparment of Clinical Embryology, Central Research Lab, Near MIS office, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9480009731  
Fax    
Email  shubha.u@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shubashree Uppangala 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Deparment of Clinical Embryology, Central Research Lab, Near MIS office, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9480009731  
Fax    
Email  shubha.u@manipal.edu  
 
Source of Monetary or Material Support  
Department of Clinical Embryology, Kasturba Medical college, Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  Department of Clinical Embryology 
Address  Department of Clinical Embryology, Central Research Lab, Near MIS office, Kasturba Medical college, Manipal Academy of Higher Education (MAHE), Manipal 
Type of Sponsor  Research institution and hospital 
 
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 
Anjali S  Kasturba Medical College  Department of Clinical Embryology, Central Research Lab, Near MIS office, Kasturba Medical College, Manipal Academy of Higher Education (MAHE), Manipal
Udupi
KARNATAKA 
9746195944

anjali.s4@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R888||Abnormal findings in other body fluids and substances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Subjects with and without PCOS, age < 35 years were included 
 
ExclusionCriteria 
Details  Patients with endometriosis, diabetics, hyperthyroidism or age > 35 years were excluded from the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
From this study we are expected to uderstand the level of testosterone and luteinizing hormone in follicular fluid, gene expression of de novo methyl transferase in granulosa cells and global methylation, ultrastructure of immature oocyte and fertilization and embryonic development  10.09.2019 to 09.09.2020 
 
Secondary Outcome  
Outcome  TimePoints 
Better understanding of PCOS characteristics  10.09.2019 to 09.09.2020 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   19/02/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Polycystic ovary syndrome (PCOS) is a common metabolic dysfunction and heterogeneous endocrine disorder in women of reproductive age. In PCOS, due to ovarian hyperandrogenism and hyperinsulinemia from insulin resistance and paracrine dysregulation of growth factors, including transforming growth factor- β (TGFβ)-related proteins disrupt the intrafollicular environment, alter granulosa cell oocyte interactions and impair cytoplasmic and/or nuclear maturation of the oocyte. However, the exact pathophysiology is remaining to be elucidated.  Recent studies have shown that there is significant changes in follicular microenvironment (Leo et al., 2016), altered gene expression profiles (Haouzi et al., 2012) and methylation pattern in granulosa cells (Sagvekar et al., 2019) derived from PCOS patients. However, none of the studies have examined the expression of de novo methyl transferases (DNMT’s) which are responsible for addition of methyl group to CpG island of promoter regions thereby altering the methylation status and regulate the gene expression of the granulosa cells. Understanding the DNMT’s expression and global methylation pattern in granulosa cells from PCOS patients and its association with altered oocyte structure will be of significant value in unravel the impact of PCOS on oocyte and embryo quality. Hence, the current study will examine the expression of DNMTs and global methylation of granulosa cells and ultra-structural modification of oocytes in women with PCOS.


 
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