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CTRI Number  CTRI/2024/11/077039 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 19/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To study the efficacy and safety of fertilix ova in ovarian reserve and ovulation induction 
Scientific Title of Study   A clinical study to evaluate the efficacy and safety of Fertilix Ova as an Add on therapy to Letrozole in Ovarian reserve and Ovulation induction. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
FERTILIXOVA/18/24, Version: 1.0, Date: 17-09-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anuradha MBBS MD 
Designation  Principal Investigator 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Department of Obstetrics and Gynecology, SRM Medical College Hospital and Research Centre

Kancheepuram
TAMIL NADU
603203
India 
Phone  9042038136  
Fax    
Email  anuradhm@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr M Sakthi Balan 
Designation  Consultant Diabetologist and CI 
Affiliation  Ki3 Pvt Ltd 
Address  Thirumalai Medical Centre, Room No 1, THirumalai Medical Centre, No 408, Cuddalore Road Nainarmandapam

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Sivakumar 
Designation  Director 
Affiliation  Ki3 Private Limited 
Address  Room No 1, Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai

Chennai
TAMIL NADU
600032
India 
Phone  9003109416  
Fax    
Email  drgayathri@ki3services.com  
 
Source of Monetary or Material Support  
Innovcare Life sciences Pvt. Ltd.,No 802, Vikas Center, Dr. C.G. Road, Chembur (E), Mumbai 400074, Maharashtra India.  
 
Primary Sponsor  
Name  Innovcare Life sciences Pvt. Ltd., India. 
Address  802, Vikas Center, Dr. C.G. Road, Chembur (E), Mumbai 400074, Maharashtra 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Dr Anuradha MBBS MD  SRM Medical College and Research Institute  Consultation Room, Department of Obstetric and gynecology, Potheri, Chengalpattu, Tamil Nadu 603203
Kancheepuram
TAMIL NADU 		 9042038136

anuradhm@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E283||Primary ovarian failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fertilix Ova  Fertilix Ova (Taken once daily orally) + Letrozole (Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5-7.5 mg mg in the next cycle if there is no response to 2.5 mg)- 12 weeks/ 3 cycles 
Comparator Agent  Letrozole  Letrozole alone- 12 weeks/ 3 cycles (Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5-7.5 mg in the next cycle if there is no response to 2.5 mg) 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Female subjects with age 21 – 45 years
2. BMI less than 35
3. Infertility due to anovulation.
4. No recent (within 6 months) treatment for induction of ovulation
5. Patient should have not participated in any other clinical trial during the past 3 months.
6. Participants, who are willing to give written, signed and dated informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Uncontrolled Diabetes (HbA1c greater than 10)
2. PCOS
3. Moderate to severe renal or hepatic impairment
4. Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity
5. Suffering from any illness which will interfere with present study as decided by clinical investigator
6. History of hypersensitivity to any of the test products.
7. Participants who are pregnant.
8. Any other condition decided as unfit for study by Clinical investigator
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measures to study the efficacy are as follows:
1. Ovulation rate – monitored by USG abdomen.
2. Ovarian reserve by monitoring Estrogen and AMH. [ time frame over 12 weeks/ 3 cycles- at baseline and post study]
3. Changes from base line to 12 weeks in Quality of life- Questionnaires (Short Form Health-12 ). [pre and post study]
 		 Day 0, Week 4, Week 8 and Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pregnancy rate
2. To demonstrate safety and tolerability of study product by Clinical AEs (If any)
Safety and tolerability evaluation criteria:
Adverse events and serious adverse events during the study period
 		 Day 0 and week 12 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3 
Date of First Enrollment (India)   30/11/2024 
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 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  
Fifty participants with Infertility/ decreased ovarian reserve & ovulation failure will be selected in two arms of 25 in each.       
Arm 1: Fertilix Ova (Taken once daily orally)  + Letrozole (Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5-7.5 mg mg in the next cycle if there is no response to 2.5 mg)- 12 weeks/ 3 cycles         
Arm 2: Letrozole alone- 12 weeks/ 3 cycles (Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5-7.5 mg in the next cycle if there is no response to 2.5 mg)
 
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