UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050227 |
|---|---|
| Receipt number | R000056881 |
| Scientific Title | Treating refractory thin endometrium through a novel way of activation and administration of Platelet-rich plasma in sexually active Syrian Women: An interventional prospective cohort clinical study |
| Date of disclosure of the study information | 2023/02/09 |
| Last modified on | 2023/02/03 14:52:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Treating infertility caused by thin endometrium through the administration of Platelet-rich plasma
Acronym
TICBTETTAOPRP
Scientific Title
Treating refractory thin
endometrium through a novel way of activation and
administration of Platelet-rich plasma in sexually active Syrian Women: An interventional prospective cohort clinical study
Scientific Title:Acronym
TRTETANWOAAAOPRPISASWAIPCCS
Region
| Asia(except Japan) |
Condition
Condition
Refractory thin endometrium
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Treating infertility caused by thin endometrium
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improving endometrial thickness and improving fertility
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A number of PRP injections in the cervix in the
location of 6 and 12 o'clock and in the quadriceps femoris and the
contralateral triceps brachii simultaneously, and PRP infusion in the uterine
cavity, the number of PRP rounds differ depending on the patient.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 22 | years-old | <= |
Age-upper limit
| 47 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients aged 22 to 47 who suffer from infertility and diagnosed with
refractory thin endometrium with:
maximal endometrial thickness of <6 mm.
low AMH levels (AMH < 1.5 ng/ml) (or normal/high AMH after
excluding other possible causes of infertility).
irregular periods.
idiopathic infertility after trying conventional treatment methods.
patients with secondary infertility after treating the underlined
cause.
Key exclusion criteria
Exclusion criteria were effective hormonal therapy, effective in-vitro
fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Haitham |
| Middle name | |
| Last name | Abbassi |
Organization
Damascus University
Division name
Obstetrics and gynecology
Zip code
N/A
Address
Damascus
TEL
00963944278160
haitham.abbassi@damascusuniversity.edu.sy
Public contact
Name of contact person
| 1st name | M SUBHI |
| Middle name | |
| Last name | MURAD |
Organization
Damascus University
Division name
Faculty of medicine
Zip code
N/A
Address
Damascus Syria
TEL
00963995666124
Homepage URL
subhimu13shiro@gmail.com
Sponsor or person
Institute
Haitham Abbassi private clinic
Institute
Department
Personal name
Funding Source
Organization
Haitham Abbassi private clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SCIENTIFIC RESEARCH ETHICS COMMITTEE (IRB) - Damascus University
Address
Damascus Syria
Tel
00963 944 226 993
raedabouharb@yahoo.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056881
