FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090610 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 31/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   A Study to See If ovarian PRP can help to Improve IVF Outcomes in Women with poor ovarian response patients 
Scientific Title of Study   The outcome of ovarian rejuvenation by PRP in Poor responder patients  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Durga G Rao 
Designation  Director of oasis fertility centre  
Affiliation  OASIS Fertility hospital -unit of Sadguru healthcare services pvt.Ltd, HYDERABAD  
Address  1st floor, Department of reproductive medicine Oasis Fertility CentreNo. 8-2-269/3/1/4, Road No. 2, near NATCO Pharma, Park View Enclave, Banjara Hills, Hyderabad, Telangana 500034 Hyderabad TELANGANA 500034 India

Hyderabad
TELANGANA
500034
India 
Phone  9490624638  
Fax    
Email  durga@oasisindia.in  
 
Details of Contact Person
Scientific Query
 
Name  DR Krishna Chaitanya  
Designation  Scientific head and HOD department of embryology  
Affiliation  OASIS Fertility hospital -unit of Sadguru healthcare services pvt.Ltd, HYDERABAD  
Address  1st floor, Department of embryology, 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

Hyderabad
TELANGANA
500034
India 
Phone  8008812999  
Fax    
Email  quality@oasisindia.in   
 
Details of Contact Person
Public Query
 
Name  DR Krishna Chaitanya  
Designation  Scientific head and HOD department of embryology  
Affiliation  OASIS Fertility hospital -unit of Sadguru healthcare services pvt.Ltd, HYDERABAD  
Address  1st floor, Department of embryology 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

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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Durga G Rao  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
Hyderabad
TELANGANA 
9490624638

durga@oasisindia.in 
Dr Nilesh Balkawade  Oasis Fertility Centre , Pune  Dynesty commercials, 2nd & 3 rd floor,, Near Chatpati Chowk, Kaspate wasti, Wakad, Pune, Maharashtra 411057
Pune
MAHARASHTRA 
8446206075

dr.nilesh@oasisindia.in 
 
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: N979||Female infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  ovarian Platelet rich plasma  PRP prepared from 40mL of autologous blood, centrifuged at 800rpm for 8minutes then supernatant rich platelets taken in another test tube and centrifuged at 2000rpm for 20minutes, supernatant was discarded and 3ml administered vaginally or laparoscopically into each ovary 
 
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). 
 
ExclusionCriteria 
Details  a) Severe endometriosis
b) Known case of genetic aberrations
c) BMI more than 30
d) Severe Male Factor Infertility
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
AFC(antral follicle count), number of oocytes retrieved, M2 (mature)oocytes, Fertilization Rate, Blastocyst Formation Rate, and Clinical Pregnancy Rate.  1 to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Gonadotropin dosage, stimulation days, Pre-trigger E2, Miscarriage rate, Cycle Cancellation Trends, On-going pregnancy rate  From time of recruitment till three to four months  
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   21/08/2025 
Date of Study Completion (India) 18/02/2026 
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 ovarian reserve (POR) is a challenging condition in assisted reproductive technology (ART), with a reported prevalence of 9 to 24 percent among women undergoing in vitro fertilization (IVF), depending on the diagnostic criteria applied. Affected individuals typically present with reduced oocyte yield, compromised embryo quality, and markedly lower live birth rates, which in severe cases may be as low as 2 to 8 percent per cycle. Existing treatment strategies, including high-dose gonadotropins and various adjuvant therapies, have demonstrated limited and inconsistent success in improving outcomes. Consequently, there is a pressing need for novel, evidence-based interventions to support this patient population. Intraovarian injection of autologous platelet-rich plasma (PRP) has recently gained attention as a potential regenerative therapy. PRP is rich in bioactive growth factors such as platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and transforming growth factor-beta (TGF-beta), which may enhance follicular activation, angiogenesis, and tissue repair when injected directly into the ovaries. Preliminary studies have reported improvements in ovarian reserve markers, including anti-Mullerian hormone (AMH) and antral follicle count (AFC), as well as encouraging trends in IVF outcomes following PRP treatment in women with POR and premature ovarian insufficiency. However, the current evidence is largely derived from small-scale, non-randomized studies, underscoring the need for rigorous clinical trials to validate its safety and efficacy.

References:

  1. Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L. ESHRE consensus on the definition of ’poor response’ to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi:10.1093/humrep/der092.

  2. Polyzos NP, Devroey P. A systematic review of randomized trials for the treatment of poor ovarian responders: is there any light at the end of the tunnel? Fertil Steril. 2011 Oct;96(4):1058-61.e7. doi:10.1016/j.fertnstert.2011.09.048.

  3. Herlihy NS, Seli E. The use of intraovarian injection of autologous platelet-rich plasma (PRP) in patients with poor ovarian response and premature ovarian insufficiency. Curr Opin Obstet Gynecol. 2022 Jun;34(3):133-137. doi:10.1097/GCO.0000000000000784.

  4. Seckin S, Ramadan H, Mouanness M, Kohansieh M, Merhi Z. Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. J Assist Reprod Genet. 2022 Jan;39(1):37-61. doi:10.1007/s10815-021-02385-w.

  5. Cakiroglu Y, Yuceturk A, Karaosmanoglu O, Kopuk SY, Korun ZEU, Herlihy N, et al. Ovarian reserve parameters and IVF outcomes in 510 women with poor ovarian response (POR) treated with intraovarian injection of autologous platelet-rich plasma (PRP). Aging (Albany NY). 2022 Mar 22;14(6):2513-2523. doi:10.18632/aging.203972.

  6. Melo P, Navarro C, Jones C, Coward K, Coleman L. The use of autologous platelet-rich plasma (PRP) versus no intervention in women with low ovarian reserve undergoing fertility treatment: a non-randomized interventional study. J Assist Reprod Genet. 2020 Apr;37(4):855-863. doi:10.1007/s10815-020-01710-z.

 
Close