Status Approved
First Submitted Date
2018/10/17
Registered Date
2018/12/07
Last Updated Date
2018/11/09
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003385 |
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Unique Protocol ID | BDCHA R&D 2015-47 |
Public/Brief Title | Autologous PRP treatment for refractory thin endometrium to enhance pregnancy and live birth rate |
Scientific Title | A pilot cohort study of autologous platelet-rich plasma in the treatment of unresponsive thin endometrium resistant to standard therapies |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | BD2015-181 |
Approval Date | 2015-12-22 |
Institutional Review Board Name | Institutional Review Board, CHA Bundang Medical Center, CHA University |
Institutional Review Board Address | 59, Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do |
Institutional Review Board Telephone | 031-780-5314 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Ji Hyang Kim |
Title | assist professor |
Telephone | +82-31-780-5200 |
Affiliation | Bundang CHA General Hospital |
Address | CHA Bundang Medical Center, 59 Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13496, Korea |
Contact Person for Public Queries | |
Name | Hounyoung Kim |
Title | Fellow |
Telephone | +82-31-780-5200 |
Affiliation | Bundang CHA General Hospital |
Address | CHA Bundang Medical Center, 59 Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13496, Korea |
Contact Person for Updating Information | |
Name | Ji Hyang Kim |
Title | assist professor |
Telephone | +82-31-780-5200 |
Affiliation | Bundang CHA General Hospital |
Address | CHA Bundang Medical Center, 59 Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13496, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2016-01-11 Actual | |
Target Number of Participant | 100 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Bundang CHA General Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2016-01-11 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Bundang CHA General Hospital |
Organization Type | Medical Institute |
Project ID | BDCHA R&D 2015-47 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Bundang CHA General Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Endometrium thickness is one of key factors for implantation of embryo. The empirical preference for endometrial thickness among clinicians is ET>7mm, and the refractory thin endometrium, which doesn’t respond to standard medical therapies, can be the etiology of recurrent implantation failure (RIF). To evaluate the effect of autologous platelet rich plasma on treating refractory thin endometrium, a prospective cohort study was designed. Women who had a history of two or more failed IVF cycles and refractory thin endometrium were enrolled in this study. The main inclusion criteria were EMT of < 7 mm after more than 2 cycles of previous medical therapy for increasing the EMT. The subjects will be treated with intrauterine infusion of autologous PRP 2 or 3 times from menstrual cycle day 10 of their frozen-thawed embryo transfer (FET) cycle, and ET will be performed 3 days after the final autologous PRP infusion. After 2 weeks, b-hCG test will be done and for those who had positive result will go under sonography to confirm G-sac. Thereafter until the delivery, timelt chart review will be done. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Non-RCT |
Intervention Type | /Biological/Vaccine, /Non-Stem Cell |
Intervention Description | The subjects were treated with intrauterine infusion of autologous Platelet rich plasma (PRP) 2 or 3 times from menstrual cycle day 10 of their frozen-thawed embryo transfer (FET) cycle, and ET was performed 3 days after the final autologous PRP infusion. The 0.5ml ~ 1ml of PRP was made with 20ml of patient own blood by centrofuge and was used within 1 hour. |
Number of Arms | 1 |
Arm 1 |
Arm Label Women who had a history of two or more failed IVF cycles and refractory thin endometrium < 7mm. |
Target Number of Participant 100 |
|
Arm Type Experimental |
|
Arm Description The subjects were treated with intrauterine infusion of autologous Platelet rich plasma (PRP) 2 or 3 times from menstrual cycle day 10 of their frozen-thawed embryo transfer (FET) cycle, and ET was performed 3 days after the final autologous PRP infusion. The 0.5ml ~ 1ml of PRP was made with 20ml of patient own blood by centrofuge and was used within 1 hour. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (N00-N99)Diseases of the genitourinary system (N97.2)Female infertility of uterine origin |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 20Year~45Year |
|
Description (a) age of 20‒45 years at the time of enrollment, (b) endometrial thickness (EMT) of <7 mm on the human chorionic gonadotropin (hCG) administration day in fresh ET cycles or on the end of estrogen priming day in frozen ET cycles in all of the previous cycles, (c) two or more failed IVF cycles, (d) more than two cycles of previous therapy for increasing the EMT, such as, hysteroscopic adhesiolysis following hormone replacement therapy, high dose estradiol valerate, transvaginal sildenafil administration, or pentoxifyilline combination with vitamin E, (e) frozen embryo available for ET, and (f) informed consent form signed. |
|
Exclusion Criteria |
(a) hematologic disorders, hemoglobin level of <9.0 g/dL or platelet count of <100,000/μL, (b) auto-immune disease, (c) chromosomal abnormality in the patient or spouse, (d) peripheral NK cell proportion of ≥12%, (e) body mass index (BMI) of ≥30 kg/m2, and (f) uncontrolled endocrine or other medical conditions, such as prolactinemia or thyroid diseases |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Live birth rate |
|
Timepoint | delivery day |
|
Secondary Outcome(s) 1 | ||
Outcome | clinical pregnancy day |
|
Timepoint | obsteteric sonography day |
|
Secondary Outcome(s) 2 | ||
Outcome | Emdometrial thickness increment |
|
Timepoint | last day of platelet rich plasa treatment day |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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