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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R888||Abnormal findings in other body fluids and substances, |
|
Intervention / Comparator Agent
|
|
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. |