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CTRI Number  CTRI/2022/05/042399 [Registered on: 06/05/2022] Trial Registered Prospectively
Last Modified On: 08/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [intra-uterine autologous platelet rich plasma instillation]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of platelet rich plasma in infertile females with thin endometrium  
Scientific Title of Study   Intrauterine instillation of autologous platelet rich plasma in infertile females with thin endometrium undergoing intrauterine insemination 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  dr divya pandey 
Designation  Associate Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  department of Obstetrics and Gynaecology,Vardhman Mahavir Medical College and Safdarjung Hospital,Delhi-29
Vardhman Mahavir Medical College and Safdarjung Hospital,Delhi-29
South
DELHI
110029
India 
Phone  8860198440  
Fax    
Email  dr_devya1@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  dr divya pandey 
Designation  Associate Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  department of Obstetrics and Gynaecology,Vardhman Mahavir Medical College and Safdarjung Hospital,Delhi-29
Vardhman Mahavir Medical College and Safdarjung Hospital,Delhi-29
South
DELHI
110029
India 
Phone  8860198440  
Fax    
Email  dr_devya1@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  dr divya pandey 
Designation  Associate Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  department of Obstetrics and Gynaecology,Vardhman Mahavir Medical College and Safdarjung Hospital,Delhi-29
Vardhman Mahavir Medical College and Safdarjung Hospital,Delhi-29
South
DELHI
110029
India 
Phone  8860198440  
Fax    
Email  dr_devya1@yahoo.co.in  
 
Source of Monetary or Material Support  
Material support by VMMC and Safdarjung hospital(governement medical college),Delhi 
 
Primary Sponsor  
Name  not applicable 
Address  not applicable 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
dr divya pandey  Safdarjung hospital   IVF centre,Department of Obstetrics and Gynaecology,Safdarjung Hospital
South
DELHI 		 8860198440

dr_devya1@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee,VMMC and Safdarjung hospital,Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  infertile female women with thin endometrium undergoing intrauterine insemination 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional treatment-estradiol valerate   Conventional treatment-estradiol valerate 6mg/day from day 8 of cycle ,onwards for 7 days 
Intervention  Intrauterine instillation of autologous Platelet rich plasma   Intrauterine instillation of autologous Platelet rich plasma in infertile females with thin endometrium undergoing intrauterine insemination. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  37.00 Year(s)
Gender  Female 
Details  1.Infertile female between 21-37 years with normal ovarian reserve (AMH:1.2-4 ng/ml;AFC:5-15) , patent both tubes and normal seminogram/ or mild male factor undergoing IUI for mild cervical factor and/ or unexplained infertility.
2. Persistent thin endometrial thickness <6 mm on ≥1 cycle in previous cycle even after conventional treatment with estradiol valearate.
3. HB>11 gm% and platelets>1.5 lakhs
 
 
ExclusionCriteria 
Details  1. History of symptoms of platelet dysfunction such as easy bruisability, frequent nose-bleeds, heavy menstrual bleeding, bleeding gums or excessive bleeding during dental procedures.
2. Blood borne disease like Hepatitis B, Hepatitis C, Syphilis, HIV.
3. NSAIDs intake in 10 days before the procedure
4. Pt on anticoagulant therapy
5. Severe Male factor for infertility
6. Tubal factor for infertility
7. WHO class 1 and 3 ovulatory dysfunction
8. Mullerian abnormality
9. Ashermann Syndrome
10. Endometritis
11. Moderate /severe endometriosis
12. Active vaginal/cervix infection/pelvic inflammatory disease.
13. Any significant co-morbidity/ psychiatric disorder which compromise or interfere with consent giving/study participation/ follow up or interpretation of study.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Change in endometrium thickness.
2)change in endometrium vascularity
 		 1)baseline,36-40 hours
2)baseline,36-40 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1)positive pregnancy rate
2)clinical pregnancy rate
 		 End point:The study will be stopped on achieving positive pregnancy or completion of three cycles of autologous PRP intrauterine instillation(whichever is earlier) 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/05/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Ni 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Background and Rationale

 

Appropriate endometrial thickness is essential for a successful pregnancy. Women with persistent thin endometrium lining in infertility programs particularly those resistant to standard therapies pose a significant clinical challenge. 

Thin or damaged endometrium remains to be a challenge in treatment of patients with infertility. Several treatment to restore endometrial thickness have been attempted e.g. exogenous estrogen,vitamin E,Sildenafil citrate and pentoxifylline.Of these, effect of estrogen is the most studies and widely used. But patients with refractory thin endometrium don’t have many options. Recently there has been use of cell proliferation method using stem cell therapy.ut there are still some unsolved issues regarding safety and usability of bone-marrow derived stem cells.Autologous Platelet rich plasma is one such option. 

The autologous PRP instilled in the endometrial cavity, results in regeneration of endometrium thereby resuming/improving menstrual bleeding and allowing implantation of fertilized ovum. The aim of the study is to assess if intrauterine administration of autologous Platelet Rich Plasma improves endometrial thickness and vascularity in females with thin endometrium and results in achieving menstrual and clinical pregnancy.


 
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