| CTRI Number |
CTRI/2021/05/033764 [Registered on: 24/05/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of autologous Platelet rich plasma in infertile females. |
|
Scientific Title of Study
|
Intrauterine instillation of autologous Platelet rich plasma in infertile females with thin endometrium undergoing intrauterine insemination: a prospective interventional study. |
| 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 PandeyY |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital,Delhi-110029. |
| Address |
Department of Obstetrics and gynecology,VMMC and Safdarjung hospital,Delhi
New Delhi
DELHI
110029
India |
| Phone |
08860198440 |
| 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,Delhi-110029. |
| Address |
Department of Obstetrics and Gynaecology ,VMMC and Safdarjung hospital,Delhi.
New Delhi
DELHI
110029
India |
| Phone |
08860198440 |
| 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,Delhi-110029. |
| Address |
department of Obstetrics and Gynaecology,VMMC and Safdarjung hospital
New Delhi
DELHI
110029
India |
| Phone |
08860198440 |
| Fax |
|
| Email |
dr_devya1@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
vmmc and safdarjung hospital delhi |
| Address |
vmmc and safdarjung hospital,new delhi-110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
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 |
Vardhman Mahavir medical college and Safdarjung hospita,Delhi |
ivf centre,Department of Obstetrics and Gynaecology,Vardhman Mahavir medical college and Safdarjung hospita,Delhi-29
New Delhi
DELHI |
08860198440
dr_devya1@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi |
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 |
Infertile women with thin endometrium undergoing IUI receiving not receiving intervention under study(i.e. no intervention) |
Infertile women with thin endometrium undergoing IUI will receive the conventional treatment for thin endometirum and not the intervention under study i.e.intra uterine autologous PRP instillation |
| Intervention |
Intrauterine instillation of autologous platelet rich plasma(PRP) in infertile women with thin Endometrium undergoing intrauterine insemination (IUI). |
Intrauterine instillation of autologous platelet rich plasma(PRP) in infertile women with thin endometrium undergoing IUI in addition to conventional treatment for thin endometirum.This will be done to see the effect on success of IUI in achieving pregnancy.
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
37.00 Year(s) |
| Gender |
Female |
| Details |
1. Infertile female between 21-37 years.
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 or 3 ovulatory dysfunction
8. Mullerian abnormality
9. Ashermann Syndrome
10. Moderate /severe endometriosis
11. Active vaginal/cervix infection/pelvic inflammatory disease.
12. 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
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome
1)Change in endometrium thickness.
2)change in endometrium vascularity
|
36-40 hours post PRP instillation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome
1)positive pregnancy rate
2).clinical pregnancy rate
|
1)positive pregnancy rate-14 DAYS after intrauterine insemination by urine pregnancy test.
2)clinical pregnancy rate-28 days after intrauterine
insemination by transvaginal ultrasound.
|
|
|
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)
|
01/06/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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.But patients with refractory thin endometrium don’t have many options. Recently there has been use of cell proliferation method using stem cell therapy.Autologous Platelet rich plasma is one such option.Platelet Rich Plasma(PRP) is blood plasma prepared from fresh whole blood which is enriched with platelets. It contains several growth factors like VEGF,FGF,EGF,PDGF,TGF and other cytokines that stimulate proliferation and growth.
The main mechanism of action is by platelet aggregation upon activation which releases intracytoplasmic granules. Activated platelets release granules by exocytosis which contain more than sixty different biologically active substances that are involved in process of tissue regeneration, angiogenesis and epithelization. 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 improving menstruation and achieving clinical pregnancy.
|