| 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
|
|
|
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
|
|
|
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:
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
|