Effects of Platelet Rich Plasma on Endometrium
Primary Purpose
Asherman Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PRP injection in the endometrium
Sponsored by
About this trial
This is an interventional treatment trial for Asherman Syndrome
Eligibility Criteria
Inclusion Criteria:
- Women in whom cycle was cancelled due to an endometrial thickness <7 mm when progesterone start was planned in patients undergoing frozen embryo transfer with hormone replacement therapy
- Women with a history of Asherman syndrome, but no obvious intrauterine adhesion in the last hysteroscopic procedure;
- Women who have at least 2 frozen good-quality embryos.
Exclusion Criteria:
- Women with any other known cause of implantation failure, such as poor embryo quality, or congenital uterine anomalies, endometrial polyp or fibroid,
- Previous diagnosis of any malignancy,
- Anticoagulant use for which plasma infusion is contraindicated,
Sites / Locations
- Acıbadem Maslak Hospital IVF Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endometrial PRP
Arm Description
Patients in whom endometrial PRP was performed
Outcomes
Primary Outcome Measures
Endometrial thickness during hormone replacement therapy
To measure endometrial thickness assessed by ultrasound during hormone replacement therapy for endometrial preparation in frozen-thawed cycles
Secondary Outcome Measures
Pregnancy outcomes after frozen-thawed embryo transfer
To assess pregnancy rates by beta-human chorionic gonadotropin and ultrasound after frozen-thawed embryo transfer cycles
Full Information
NCT ID
NCT04424160
First Posted
June 4, 2020
Last Updated
April 19, 2021
Sponsor
Acibadem University
Collaborators
Baskent University
1. Study Identification
Unique Protocol Identification Number
NCT04424160
Brief Title
Effects of Platelet Rich Plasma on Endometrium
Official Title
Effects of Intrauterine Platelet Rich Plasma (PRP) on Endometrium and Pregnancy Rates in Patients With Suboptimal Endometrium Undergoing Frozen Embryo Transfer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
April 19, 2021 (Actual)
Study Completion Date
April 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University
Collaborators
Baskent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. The endometrial thickness will be assessed under ultrasound and hormone replacement will be started. As the endometrial thickness reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed.
Detailed Description
Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. In the second menstrual period following the PRP injection, the endometrial thickness will be assessed under ultrasound and hormone replacement will be started. As the endometrial thickness reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed. Pregnancy test results will be recorded and followed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asherman Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into the endometrial region of the endometrium in several positions.On the same day after the procedure, the patient will be observed in the outpatient room and will be discharged on the same day. On the second menstrual cycle after the procedure, the patients will be checked under ultrasound and will be started hormone replacement therapy for embryo transfer.
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endometrial PRP
Arm Type
Experimental
Arm Description
Patients in whom endometrial PRP was performed
Intervention Type
Biological
Intervention Name(s)
PRP injection in the endometrium
Intervention Description
Within 5 days after the cessation of menstrual period, endometrial PRP procedure will be planned. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into the endometrial region of the endometrium in several positions.On the same day after the procedure, the patient will be observed in the outpatient room and will be discharged on the same day.
Primary Outcome Measure Information:
Title
Endometrial thickness during hormone replacement therapy
Description
To measure endometrial thickness assessed by ultrasound during hormone replacement therapy for endometrial preparation in frozen-thawed cycles
Time Frame
2-10 months
Secondary Outcome Measure Information:
Title
Pregnancy outcomes after frozen-thawed embryo transfer
Description
To assess pregnancy rates by beta-human chorionic gonadotropin and ultrasound after frozen-thawed embryo transfer cycles
Time Frame
2-10 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
All infertile women desiring pregnancy
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women in whom cycle was cancelled due to an endometrial thickness <7 mm when progesterone start was planned in patients undergoing frozen embryo transfer with hormone replacement therapy
Women with a history of Asherman syndrome, but no obvious intrauterine adhesion in the last hysteroscopic procedure;
Women who have at least 2 frozen good-quality embryos.
Exclusion Criteria:
Women with any other known cause of implantation failure, such as poor embryo quality, or congenital uterine anomalies, endometrial polyp or fibroid,
Previous diagnosis of any malignancy,
Anticoagulant use for which plasma infusion is contraindicated,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hulusi Bulent Zeyneloglu, Prof
Organizational Affiliation
Baskent University Departments of Obstetrics and Gynecology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yigit Cakiroglu, Assoc.Prof.
Organizational Affiliation
Acibadem University
Official's Role
Study Director
Facility Information:
Facility Name
Acıbadem Maslak Hospital IVF Unit
City
Istanbul
ZIP/Postal Code
34460
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25785127
Citation
Chang Y, Li J, Chen Y, Wei L, Yang X, Shi Y, Liang X. Autologous platelet-rich plasma promotes endometrial growth and improves pregnancy outcome during in vitro fertilization. Int J Clin Exp Med. 2015 Jan 15;8(1):1286-90. eCollection 2015.
Results Reference
result
PubMed Identifier
29142450
Citation
Tandulwadkar SR, Naralkar MV, Surana AD, Selvakarthick M, Kharat AH. Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. J Hum Reprod Sci. 2017 Jul-Sep;10(3):208-212. doi: 10.4103/jhrs.JHRS_28_17.
Results Reference
result
PubMed Identifier
28333034
Citation
Zadehmodarres S, Salehpour S, Saharkhiz N, Nazari L. Treatment of thin endometrium with autologous platelet-rich plasma: a pilot study. JBRA Assist Reprod. 2017 Feb 1;21(1):54-56. doi: 10.5935/1518-0557.20170013.
Results Reference
result
PubMed Identifier
30653117
Citation
Chang Y, Li J, Wei LN, Pang J, Chen J, Liang X. Autologous platelet-rich plasma infusion improves clinical pregnancy rate in frozen embryo transfer cycles for women with thin endometrium. Medicine (Baltimore). 2019 Jan;98(3):e14062. doi: 10.1097/MD.0000000000014062.
Results Reference
result
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Effects of Platelet Rich Plasma on Endometrium
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