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CTRI Number  CTRI/2025/02/080584 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Two Treatment Methods for Women with Low Ovarian Reserve Who Struggle to Respond to IVF, to See Which One Works Better 
Scientific Title of Study   Comparing IVF Outcomes of Progestin Primed Ovarian stimulation(PPOS) with Ultrashort flare(USF)GnRH Agonist in Expected Poor responders(POSEIDON 3,4)-A Multicentric Randomised controlled Trail 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  POOJITHA CH 
Designation  FNB FELLOW 
Affiliation  OASIS Fertility hospital -unit of Sadguru healthcare services pvt.Ltd, HYDERABAD  
Address  No. 8-2-269/3/1/4, Road No. 2, near NATCO Pharma, Park View Enclave, Banjara Hills, Hyderabad, Telangana 500034

Hyderabad
TELANGANA
500034
India 
Phone  08897262122  
Fax    
Email  chalamalasettypoojitha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrKrishna chaitanya  
Designation  Scientific head and HOD department of embryology  
Affiliation  OASIS Fertility hospital -unit of Sadguru healthcare services pvt.Ltd, HYDERABAD 
Address  No. 8-2-269/3/1/4, Road No. 2, near NATCO Pharma, Park View Enclave, Banjara Hills, Hyderabad, Telangana 500034

Hyderabad
TELANGANA
500034
India 
Phone  8008812999  
Fax    
Email  quality@oasisindia.in  
 
Details of Contact Person
Public Query  
Name  DrKrishna chaitanya  
Designation  Scientific head and HOD department of embryology  
Affiliation  OASIS Fertility hospital -unit of Sadguru healthcare services pvt.Ltd, HYDERABAD 
Address  No. 8-2-269/3/1/4, Road No. 2, near NATCO Pharma, Park View Enclave, Banjara Hills, Hyderabad, Telangana 500034

Hyderabad
TELANGANA
500034
India 
Phone  8008812999  
Fax    
Email  quality@oasisindia.in  
 
Source of Monetary or Material Support  
Oasis Fertility Centre No. 8-2-269/3/1/4, Road No. 2, Near NATCO Pharma, Park View Enclave, Banjara Hills, Hyderabad, Telangana 500034 
 
Primary Sponsor  
Name  Oasis Fertility Centre  
Address  No. 8-2-269/3/1/4, Road No. 2, Near NATCO Pharma, Park View Enclave, Banjara Hills, Hyderabad, Telangana 500034 
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 = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Poojithach  Oasis Fertility Centre   No. 8-2-269/3/1/4, Road No. 2, Near NATCO Pharma, Park View Enclave, Banjara Hills, Hyderabad, Telangana 500034.
Hyderabad
TELANGANA 		 08897262122

chalamalasettypoojitha@gmail.com 
Dr Poojithach  Oasis Fertility Centre   Oxford Street, Sarojini Devi Road 2nd Floor CVK Park Square, Krishna Complex, Kalasiguda, Secunderabad, Telangana 500003.
Hyderabad
TELANGANA 		 08897262122

chalamalasettypoojitha@gmail.com 
Dr Poojithach  Oasis Fertility Centre   2nd & 3rd Floor, 16-2-741/29 & 57, NH 65, Bank Colony, New Malakpet,Dilsukhnagar,Hyderabad, Telangana 500036
Hyderabad
TELANGANA 		 08897262122

chalamalasettypoojitha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Oasis Ethics Committee   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 
Intervention  Progestin primed ovarian stimulation (PPOS)  T.Medroxy progesterone acetate 10 mg once daily orally along with gonadotrophins from D2 of menstrual cycle (maximum dose 375 IU of HP HMG +- r FSH /r FSH + r LH per day ). When two or more follicles reaches 18 mm, dual trigger was given,medroxyprogesterone acetate tablet stopped,followed by transvaginal oocyte retrieval at 35-36 hours. ICSI was done followed by elective cryopreservation and frozen embryo transfer and bHCG after 2 weeks followed for 3 months if bHCG positive . 
Comparator Agent  Ultrashort flare GnRH agonist protocol (USF)  Inj Lupride 1 mg s.c will be given for four days from D1/D2 of menstrual cycle along with gonadotropins from D2/D3 of menstrual cycle (maximum dose 375 IU of HP HMG +- r FSH /r FSH + r LH per day ) Inj cetrotide 0.25 mg s.c/day was added when follicle crosses 14 mm and when two or more follicles reaches 18 mm, dual trigger was given .Transvaginal oocyte retrieval at 35-36 hours. ICSI was done followed by elective cryopreservation and frozen embryo transfer bHCG after 2 weeks followed for 3 months if bHCG positive . 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Expected Poor responders as defined by POSEIDON criteria (Groups 3-4).
Freeze all cycles  
 
ExclusionCriteria 
Details  Women with any current or past diseases affecting ovaries
Hypogonadotrophic hypogonadism

Premature ovarian insufficiency  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Oocyte Retrieval Rate,Maturation rate ,Fertilization rate, ,blastulation rate .  Till 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
days of stimulation ,Total gonadotropin dosage ,cycle cancellation rate , Follicular output rate(FORT) ,Follicle to oocyte index(FOI ),Implantation rate (IR),Biochemical pregnancy(BPR),Clinical pregnancy rate (CPR),Miscarriage rate (MR),Multiple pregnancy rate (MPR) ,Utilization rate  From time of recruitment till three to four months  
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   24/02/2025 
Date of Study Completion (India) 21/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Poor responders constitute approximately 47% of assisted reproductive technology (ART) patients. With the increasing delay in childbearing, POSEIDON group 4 seems to increase constituting more than 50% of the total POSEIDON population, whereas group 3 patients constitute approximately 10%(1). Inspite of various treatment options available, there are lack of good quality studies to suggest the stimulation protocol for better results in women with poor ovarian reserve .Also ,need for multiple stimulations for pooling up of embryos also make cost as concern. The recommendations from ESHRE regarding the use of PPOS for IVF stimulation are conditional, emphasizing the need for more robust and high-quality studies.However, limited data were available to compare the efficacy of PPOS and Ultrashort flare GnRH agonist protocol in expected poor responders.
There are previous studies comparing ppos with GnRH antagonist protocol retrospectively with no difference in CLBR  by Zhang et al in china (2)
But there were no randomised controlled trails in poseidon population comparing ppos with ultra short flare GnRH agonist protocol 
 so we need a Randomized controlled trial to investigate the potential of PPOS and USF GnRH agonist protocol used for the poor responders undergoing IVF/ICSI treatment to suggest better stimulation in terms of cost , compliance and IVF outcomes.

1.Conforti A, Esteves SC, Picarelli S, Iorio G, Rania E, Zullo F, et al. Novel approaches for diagnosis and management of low prognosis patients in assisted reproductive technology: the POSEIDON concept. Panminerva Med. (2019) 61:24–9. 10.23736/S0031-0808.18.03511-5 [DOI] [PubMed] [Google Scholar]
2.Zhang S, Yin Y, Li Q, Zhang C. Comparison of Cumulative Live Birth Rates Between GnRH-A and PPOS in Low-Prognosis Patients According to POSEIDON Criteria: A Cohort Study. Front Endocrinol (Lausanne). 2021 Jun 21;12:644456. doi: 10.3389/fendo.2021.644456. PMID: 34234739; PMCID: PMC8256850.

 
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