| CTRI Number |
CTRI/2025/12/099341 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
14/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Other (Specify) [PLATLET RICH PLASMA] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Platelet Rich Plasma for endometrial regeneration in infertile women |
|
Scientific Title of Study
|
Comparison of the effect of Intrauterine Platelet Rich Plasma instillation to oestradiol valerate alone in infertile women with thin endometrium undergoing Ovarian Stimulation: An Open Labelled Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya leela Kayala |
| Designation |
junior resident |
| Affiliation |
AIIMS PATNA |
| Address |
Room no 237 ,Department of Obstetrics and Gynecology,OPD building,AIIMS,Patna, Phulwarisharif,Patna,Bihar,801507
Room no 237 ,Department of Obstetrics and Gynecology,OPD building,AIIMS,Patna, Phulwarisharif,Patna,Bihar,801507
Patna
BIHAR
801507
India |
| Phone |
9505073759 |
| Fax |
|
| Email |
divya14146@aiimspatna.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya leela Kayala |
| Designation |
junior resident |
| Affiliation |
AIIMS PATNA |
| Address |
Room no 237 ,Department of Obstetrics and Gynecology,OPD building,AIIMS,Patna, Phulwarisharif,Patna,Bihar,801507
Room no 237 ,Department of Obstetrics and Gynecology,OPD building,AIIMS,Patna, Phulwarisharif,Patna,Bihar,801507
Patna
BIHAR
801507
India |
| Phone |
9505073759 |
| Fax |
|
| Email |
divya14146@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Indira Prasad |
| Designation |
Additional professor |
| Affiliation |
AIIMS PATNA |
| Address |
Room no 242 ,Department of Obstetrics and Gynecology,OPD building,AIIMS,Patna, Phulwarisharif,Patna,Bihar,801507
Room no 242 ,Department of Obstetrics and Gynecology,OPD building,AIIMS,Patna, Phulwarisharif,Patna,Bihar,801507
Patna
BIHAR
801507
India |
| Phone |
8860033085 |
| Fax |
|
| Email |
drindirap@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS PATNA |
| Address |
Aiims patna pulwarisharif patna bihar 801507 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS PATNA |
Aiims patna pulwarisharif patna bihar 801507 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Divya Leela Kayala |
AIIMS PATNA |
room no 242, obstetrics and gynecology department, OPD building Aiims patna pulwarisharif patna bihar 801507
Patna
BIHAR |
9505073759
divya14146@aiimspatna.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
estradiol valerate |
giving estradiol valerate in infertle women with thin endometrium |
| Intervention |
PRP instillation |
3ml of PRP instillation intrauterine using intrauterine catheter once over 10 mins in addition to estradiol valerate in infertile women with thin endometrium |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
infertile women aged 20 to 40 years with endometrial thickness of less than 7mm
platelets greater than 1,50,000 |
|
| ExclusionCriteria |
| Details |
NSAID intake 3 days before procedure
patient on anticoagulation therapy
severe male infertility factor
tubal factors
mullerian anomalies
asherman syndrome
moderate to severe endometriosis
platelet count less than 1,50,000
diseases such as hepatitis B,hepatitis C,syphilis,HIV
active vaginal or cervical infections
pelvic inflammatory disease |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| increase in endometrial thickness and endometrial vascularity |
48 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
biochemical pregnancy rate
clinical pregnancy rate
live birth rate |
1 month
2 months
12 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 4 |
|
Date of First Enrollment (India)
|
29/12/2025 |
| 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="6"
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
|
Thin endometrium is a significant barrier to successful implantation in infertile women undergoing ovarian stimulation. Endometrial thickness (ET) less than 7 mm is associated with reduced pregnancy rates. Conventional treatment includes estradiol valerate; however, recent studies suggest intrauterine Platelet Rich Plasma (PRP) may enhance endometrial growth and vascularity. This open-labelled randomized controlled trial aims to compare the effects of PRP instillation combined with estradiol valerate versus estradiol valerate alone in infertile women with thin endometrium. The primary objective is to assess changes in ET and endometrial vascularity, while secondary outcomes include pregnancy and live birth rates. The study involves 56 participants randomized into two groups, with pre- and post-intervention ultrasound assessments. If effective, PRP could become a recommended adjunct in thin endometrium management. |