| CTRI Number |
CTRI/2024/11/076262 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Process of Care Changes
Other (Specify) [Intrauterine PRP infusion] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Endometrial Perfusion of Platelet Rich Plasma (PRP) in IVF patients |
|
Scientific Title of Study
|
Effect of Endometrial Perfusion of Platelet Rich Plasma (PRP) on success of Frozen Embryo Transfer (FET) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushboo Shah |
| Designation |
JR1 obstetrics and gynaecology |
| Affiliation |
Datta Meghe institute of higher education and research |
| Address |
Department of obstetrics and gynaecology ,Ground floor,AVBRH Building , Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8169308850 |
| Fax |
|
| Email |
khushicool200@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepti Shrivastava |
| Designation |
Professor, HOU Dept of Obstetrics and Gynaecology J.N.M.C Sawangi (Meghe)Wardha(MH) |
| Affiliation |
Datta Meghe institute of higher education and research |
| Address |
Professor, HOU
Dept of Obstetrics and Gynaecology
J.N.M.C Sawangi
(Meghe)Wardha(MH)
Datta Meghe institute of higher education and research , Sawangi Meghe -442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860817801 |
| Fax |
|
| Email |
deepti_shrivastava69@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushboo Shah |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe institute of higher education and research |
| Address |
Department of obstetrics and gynaecology ,Ground floor,AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8169308850 |
| Fax |
|
| Email |
khushicool200@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education And Research,Sawangi Meghe, Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education And Research,Sawangi Meghe, Wardha India 442001 |
| Address |
Sawangi Meghe, Wardha India 442001 |
| Type of Sponsor |
Private 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 Khushboo Shah |
Datta Meghe Institute of Higher Education and Research |
Department of Obstetrics and Gynaecology,AVBRH hospital, DMIHER Campus, Sawangi Meghe, Wardha India 442001
Wardha
MAHARASHTRA |
8169308850
khushicool200@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Instituute Of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Platelet rich Plasma |
Patients with PRP intrauterine perfusion on endometrial transformation day will be correlated with Frozen embryo transfer women who received intrauterine perfusion of Platelet rich plasma. |
| Comparator Agent |
Without Platelet Rich Plasma |
Patients with PRP intrauterine perfusion on endometrial transformation day will be correlated with Frozen embryo transfer women who did not receive intrauterine perfusion of Platelet rich plasma. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Women aged 18- 45 yrs
2.The lack of contraindications for PRP treatment ( Hb-less than 10gm%, low platelet count, sickle cell disease, chronic neutropenia, known past or present malignancy, renal insufficiency, upper respiratory infection, pneumonia anf congenital fructose intolerance)
3.Women with a normal transvaginal ultrasound and no evidence of a clinically significant abnormality in the uterus or adnexa.
4.Negative CBNAAT, AFB staining and TBPCR for genital tuberculosis. |
|
| ExclusionCriteria |
| Details |
1.Patients with BMI greater than 30 kg/m2
2.Positive history of intrauterine synechiae, repeated currettage, endometrial injury
3.Distorted endometrial cavity because of recurrent adhesions, submucosal fibroids, endometrial polyps, severe endometriosis, adenomyosis, pelvic cancer and uterine anomalies.
4.Chromosomal abnormalities in couples.
5.Patients with abnormal liver and kidney function, abnormal thyroid function, immune disorders or hematological disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of positive Beta HCG , positive UPT, appearance of gestational sac and cardiac activity on USG |
Assessment will be done after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/12/2024 |
| 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="2"
Months="0"
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
|
The assisted reproductive technology (ART) method of frozen embryo transfer (FET) is now often used to produce healthy babies. Adjunctive medications to enhance endometrial receptivity are being investigated, nevertheless, because implantation failure continues to be a major obstacle. Endometrial perfusion and responsiveness may be modulated by platelet-rich plasma (PRP), which is abundant in growth factors and cytokines.
In order to assess the impact of PRP endometrial perfusion on the success of frozen embryo transfer, this abstract undertakes a meta-analysis of the literature. Research examining the effect of PRP on FET outcomes was included in the eligible papers, which also included prospective cohort studies and retrospective analyses.
When comparing the clinical pregnancy rates of women undergoing FET with endometrial perfusion of PRP to controls, a pooled analysis of data from specific studies shows a substantial improvement (p < 0.05). Moreover, a dose-response relationship is suggested by the positive association shown by meta-regression analysis between the concentration of platelets in PRP and pregnancy outcomes.
Subgroup studies that take into account the patient’s demographics, the cause of their infertility, and the methods used to prepare PRP offer valuable information on possible causes of heterogeneity and variances in treatment outcomes. Notably, there is no discernible rise in adverse events recorded across studies, suggesting that PRP treatment has a positive safety profile.
Although the results indicate that PRP may be useful in improving endometrial receptivity and FET success, there are a number of limitations that should be taken into consideration when interpreting the results. These include limited sample sizes, heterogeneity in study designs, and variability in PRP preparation techniques. Larger sample sizes and more carefully planned RCTs are required in the future to confirm these results and clarify the best PRP delivery schedule for enhancing FET outcomes.
To sum up, endometrial perfusion of PRP exhibits potential as a viable adjuvant therapy to augment the effectiveness of frozen embryo transfer, providing fresh opportunities to improve patient outcomes and pregnancy rates in assisted reproductive environments. |