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CTRI Number  CTRI/2022/08/044606 [Registered on: 03/08/2022] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Investigator initiate study to compare 0.2 mg vs 0.3 mg GnRH agonist trigger in ART  
Scientific Title of Study
Modification(s)  		 Comparison of ART outcome in 0.2 mg GnRH agonist trigger vs 0.3 mg GnRH agonist trigger in Poor ovarian reserve females, a randomized clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IIHPL-UDR/RCT/001_2021 Ver 2.0 Dated 19 April 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kshitiz Murdia 
Designation  IVF Specialist 
Affiliation  Indira IVF Hospital Pvt Ltd 
Address  Fourth Floor, Department of Reproductive Medicine ,IIHPL 44, Amar Niwas, kumbharon ka Bhatta, Opp MB Colleg

Udaipur
RAJASTHAN
313001
India 
Phone  9799112244  
Fax    
Email  kshitiz.murdia@indiraivf.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nihar Bhoi 
Designation  Head Clinical and Audit 
Affiliation  Indira IVF Hospital Pvt Ltd 
Address  Fourth Floor, Department of Reproductive Medicine ,IIHPL 44, Amar Niwas, kumbharon ka Bhatta, Opp MB College

Udaipur
RAJASTHAN
313001
India 
Phone  7205783512  
Fax    
Email  drnihar.bhoi@indiraivf.in  
 
Details of Contact Person
Public Query  
Name  Dr Nihar Bhoi 
Designation  Head Clinical and Audit 
Affiliation  Indira IVF Hospital Pvt Ltd 
Address  Fourth Floor, Department of Reproductive Medicine ,IIHPL 44, Amar Niwas, kumbharon ka Bhatta, Opp MB College

Udaipur
RAJASTHAN
313001
India 
Phone  7205783512  
Fax    
Email  drnihar.bhoi@indiraivf.in  
 
Source of Monetary or Material Support  
Indira IVF Hospital Pvt Ltd,Udaipur 
 
Primary Sponsor  
Name  Indira IVF Hospital Pvt Ltd 
Address  44 Amar Niwas Kumharon ka bhatta Udaipur 
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 = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amrita Das  Indira IVF hospital Delhi  Opposite Metro Pillar 203, Near Patel Nagar Metro Station, New Delhi-110008
New Delhi
DELHI 		 7002113877

dramritadas.delhi@indiraivf.in 
Dr Akanksha Jangid  Indira IVF hospital Kolkata  Pataka House, 3rd 57-B, Mirza Ghalib St, Park Street, Kolkata, 700016
Kolkata
WEST BENGAL 		 9781541418

centerhead.kolkata@indiraivf.in 
Dr Pawan Yadav  Indira IVF hospital Lucknow  Rana Pratap Marg, Opp National PG College, Hazratgunj, Lucknow - 226001, Uttar Pradesh (UP) India
Lucknow
UTTAR PRADESH 		 7205783512

centerhead.lucknow@indiraivf.in 
Dr Anjali Gahlan  Indira IVF Hospital Prayagraj  Near Hanuman Mandir, Lal Bahadur Shastri Marg, Allahabad - 211001, Uttar Pradesh, India
Allahabad
UTTAR PRADESH 		 9793116314

centerhead.allahabad@indiraivf.in 
Dr Amol Lunkad  Indira IVF hospital Pune  Near Symbiosis College, New Airport, Road, Viman Nagar, Pune - 411014, Maharashtra
Pune
MAHARASHTRA 		 8237834121

dramollunkad@indiraivf.in 
Dr Kshitiz Murdia  Indira IVF hospital Udaipur  44, Amar Niwas, kumbharon ka Bhatta, Udaipur.
Udaipur
RAJASTHAN 		 9799112244

kshitiz.murdia@indiraivf.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Indira IVF Hospital Institutional Ethics Committee (Bangalore)  Approved 
Indira IVF Hospital Institutional Ethics Committee (Delhi)  Approved 
Indira IVF Hospital Institutional Ethics Committee (Hyderabad)  Approved 
Indira IVF Hospital Institutional Ethics Committee (Patna)  Approved 
Indira IVF Hospital Institutional Ethics Committee (Udaipur)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O090||Supervision of pregnancy with history of infertility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  triptorelin acetate(0.2mg)   trigger final oocyte maturation 36 hrs prior to ovum pickup using 0.2mg triptorelin acetate (GnRH agonist) Subcutaneous Route 
Intervention  triptorelin acetate(0.3mg)   trigger Agonist 36 hrs before ovum pickup final oocyte maturation trigger using 0.3mg triptorelin acetate (GnRH agonist) Subcutaneous Route  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1) Antral follicle count on day 2 of menses <5
2) AMH < 1.2 ng /dl
 
 
ExclusionCriteria 
Details  1) BMI; ≥ 30 kg/m2
2) Presence of endocrine disorders; (uncontrolled diabetes mellitus, / hyperprolactinemia, thyroid dysfunction,
3) Congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome
4)Previous major uterine surgery
5)Donor oocyte cycle.
6) Gestational carrier
7) Fertility preservation.
8) Adenomyosis
9) Endometriosis
10) Premature ovarian failure.
11) Thin endometrium <6mm after 21 days of HRT (oestradiol valerate).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Percentage of mature oocytes retrieval  on the day of ovum of Pick up 
 
Secondary Outcome  
Outcome  TimePoints 
Follicle oocyte index  On the day of ovum pick-up
10- 15 days of start of simulation  
Oocyte retrieval rate   On the day of ovum pick-up
10- 15 days of start of simulation  
Implantation rate   4- 6 weeks after embryo transfer  
Clinical pregnancy rate  4-6 weeks after embryo transfer 
Ongoing pregnancy rate  12th week of gestation  
OHSS occurrence rate  4 weeks from ovum pick up  
 
Target Sample Size   Total Sample Size="654"
Sample Size from India="654" 
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)   06/08/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Suspended 
Publication Details   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Background: Human chorionic gonadotrophin (HCG) has been successfully used for decades as a surrogate for the natural LH surge for oocyte maturation during IVF cycles. Gonadotrophin releasing hormone agonist as the trigger was introduced for IVF in high responders to minimize the risk of OHSS but with a compromised pregnancy rate because of luteolytic action. The FSH surge in combination with the direct action of GnRH on ovarian receptors may explain the role of the agonist trigger Shapiro et al. demonstrated that acceptable fertilization rates, implantation, clinical pregnancy, ongoing pregnancy, and early pregnancy loss could still be obtained using a dual trigger in a population of high responders. These findings further indicated that GnRH agonist has important roles in oocyte maturation and embryo implantation. Keeping in view the promising result in high and normal responders, we wish to demonstrate the role of dual trigger in poor responders. Objective:To explore whether a 0.3 mg triptorelin acetate for final oocyte maturation could improve oocyte quality and subsequently the IVF outcomes of patients with POR as compare to that of 0.2 mg Triptorelin acetate.

. Primary measurable outcome: Percentage of mature oocytes retrieved: Percentage of mature oocytes retrieved following oocyte retrieval: (Total number of m2 oocytes per 100 retrieved oocytes). Secondary Measurable outcome:
 

·  Follicle oocyte index: The ratio between the number of oocytes collected at the Ovum pick up and the number of antral follicles at the beginning of OS

·  Oocyte retrieval rate: number of retrieved oocytes per 100 expected Oocytes from follicles more than 14mm in diameter on the trigger day

·   Implantation rate: Number of intrauterine gestational sacs observed by transvaginal ultrasonography per 100  transferred embryos.

·   Clinical pregnancy rate: Number of patients with USG suggestive of Foetal Heart Rate at 6 to 7 weeks per 100 Embryo transfer cycle

·   Ongoing pregnancy rate: Presence of gestational sacs with a heartbeat at the 12th gestational week.

This is a prospective, open-label, multicenter, randomized, parallel-group study to be conducted in 654 women in the age group of 25 to 40 years (both inclusive), who are indicated to undergo COS as part of ART. Each woman will participate in the study for a maximum duration of approximately 28 weeks after signing the informed consent form (ICF). This will include a screening period, a single cycle of COS and ART procedures, and post-ART follow-up for ongoing pregnancy till 12 completed wks of gestation.

·    OHSS occurrence rate.

 

 
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