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CTRI Number  CTRI/2024/11/076993 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of Tablet Eggrich in oocyte quality 
Scientific Title of Study   A prospective study to evaluate safety and efficacy of Egrich tablets on oocyte quality in women undergoing invitro fertilization (IVF) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abinaya Durasisingam 
Designation  Fertility consultant  
Affiliation  Department of Reproductive medicine and Endocrinology 
Address  Room No: 5 A4 Hospital and Fertility centre 87 Arcot road, virugampakkam

Chennai
TAMIL NADU
600092
India 
Phone  09841269578  
Fax    
Email  dr.abinaya@a4fertility.com  
 
Details of Contact Person
Scientific Query  
Name  Abinaya Durasisingam 
Designation  Fertility consultant  
Affiliation  Department of Reproductive medicine and Endocrinology 
Address  Room no: 5 A4 Hospital and Fertility centre 87 Arcot road, virugampakkam

Chennai
TAMIL NADU
600092
India 
Phone  09841269578  
Fax    
Email  dr.abinaya@a4fertility.com  
 
Details of Contact Person
Public Query  
Name  Abinaya Durasisingam 
Designation  Fertility consultant  
Affiliation  Department of Reproductive medicine and Endocrinology 
Address  Room no: 5 A4 Hospital and Fertility centre 87 Arcot road , virugampakkam

Chennai
TAMIL NADU
600092
India 
Phone  09841269578  
Fax    
Email  dr.abinaya@a4fertility.com  
 
Source of Monetary or Material Support  
A4 Fertility centre No 87 Arcot road virugambakkam chennai - 600092 
 
Primary Sponsor  
Name  DrAbinaya  
Address  A4 Hospital and Fertility centre No 87 Arcot road,AVM Avenue, virugambakkam chennai - 600092 Tamilnadu 
Type of Sponsor  Private hospital/clinic 
 
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 
DrAbinaya   A4 Hospital and Fertility centre  87, Arcot Rd, AVM Avenue, Virugambakkam, Chennai, Tamil Nadu 600092
Chennai
TAMIL NADU 		 9677994419

dr.abinaya@a4fertility.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
A4 Hospital - instituitional ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N970||Female infertility associated withanovulation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj.GCSF and T.EGRICH  Inj.GCSF 300 mcg 2 doses on Day 18 of menstrual cycle for consecutive 2 months and T.EGRICH one tablet twice a day for 3 months  
Comparator Agent  T.CO Q Enzyme and placebo injection   T.CO Q Enzyme 200 mg twice a day for 3 months placebo injcetion 2 doses on Day 18 of menstrual cycle for consecutive 2 months 
Intervention  T.EGRICH and Placebo injection   T.EGRICH one tablet twice daily for a period of 3 months Placebo injection 2 doses on Day 18 of menstrual cycle for consecutive 2 months  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Presence of factors indicating compromised oocyte quality (advanced maternal age or previous IVF failures).
Subjects with prior history of poor oocyte quality in terms of maturity on retrieval.
Subjects who couldn’t meet the benchmark blastocyst conversion rate
Female subjects who are willing to commit the study restrictions.
 
 
ExclusionCriteria 
Details  Subjects with endometriosis involving uterus, ovaries, bladder, fallopian tubes, pelvis or deeply infiltrating endometriosis.
Subjects with diagnosis of HIV, HCV, HBV, VDRL and other sexually transmitted diseases.
Known allergy or hypersensitivity to any components of Egrich tablets.
History of significant medical conditions affecting fertility or pregnancy outcome.
Use of medications known to impact fertility or oocyte quality within the past three months.
Male factor such as SOAT (total count less than 1 million per ml)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in oocyte quality, measured by the number of competent metaphase II (MII) oocytes retrieved after IVF.
 		 Three months 
 
Secondary Outcome  
Outcome  TimePoints 
Fertilization rate.
Embryo quality (morphological scoring of embryos).
Clinical pregnancy rate (confirmation via ultrasound of fetal heartbeat at 6–8 weeks post-transfer).
Incidence of any adverse events during treatment.
 		 3 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   05/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/12/2025 
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 Yet Recruiting 
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  
•INFERTILITY IS A WIDESPREAD CONCERN AFFECTING APPROXIMATELY 10-15% OF COUPLES WORLDWIDE, DEFINED AS THE INABILITY TO CONCEIVE AFTER ONE YEAR OF UNPROTECTED INTERCOURSE.
•FEMALE INFERTILITY IS RESPONSIBLE FOR 30-40% OF INFERTILITY CASES.
•POOR-QUALITY OOCYTES OFTEN LEAD TO FAILED FERTILIZATION, EARLY EMBRYONIC ARREST, CHROMOSOMAL ANOMALIES, AND MISCARRIAGE.
•FOR SUCCESSFUL PREGNANCY, AN OOCYTE MUST HAVE THE CAPACITY TO UNDERGO FERTILIZATION, INITIATE EMBRYONIC DIVISION, AND SUSTAIN HEALTHY DEVELOPMENT TO THE BLASTOCYST STAGE.
EGRICH CONTAINS  COENZYME Q10 -150 MG, DEHYDROEPIANDROSTERONE (DHEA) 40 MG, GAMMA TOCOTRIENOL 12.5 MG, ZINC SULPHATE 12.5 MG POLICOSANOL -10 MG, L-TRYPTOPHAN-1.5 MG, CHOLECALCIFEROL- 600 IU. ALL OF THESE COMPONENTS IMPROVE THE OOCYTE QUALITY AND ALSO REDUCES OXIATIVE STRESS WITHIN THE OCCYTES. 
INJ GCSF IS GRANULOCYTE COLONY STIMULATING FACTOR, WHICH IMPROVES OVARIAN PREANTRAL FOLLICLES AND ALSO ANTI-MULLERIAN HORMONE IN PATIENTS WITH  DIMINISHED OVARIAN RESERVE . IT ALSO IMPROVED EMBRYONIC IMPROVEMENT AND PREGNANCY RATE.
 
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