Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair (PRP-E)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02825849 |
|
Recruitment Status :
Terminated
(Low recruitment and competing studies have published.)
First Posted : July 7, 2016
Results First Posted : February 9, 2021
Last Update Posted : February 9, 2021
|
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Conditions |
Infertility Asherman's Syndrome |
| Intervention |
Biological: Intrauterine infusion of platelet rich plasma |
| Enrollment | 27 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | PRP Intrauterine Infusion | Control Group With Standard Treatment Only |
|---|---|---|
 Arm/Group Description |
Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles Intrauterine infusion of platelet rich plasma: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP. |
Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols |
| Period Title: Overall Study | ||
| Started | 22 | 5 |
| Completed | 22 | 5 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | PRP Intrauterine Infusion | Control Group With Standard Treatment Only | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles Intrauterine infusion of platelet rich plasma: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP. |
Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols | Total of all reporting groups | |
| Overall Number of Baseline Participants | 22 | 5 | 27 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 22 participants | 5 participants | 27 participants | |
| 37.9 (3.2) | 35.6 (6.3) | 37.5 (3.9) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 22 participants | 5 participants | 27 participants | |
| Female |
22 100.0%
|
5 100.0%
|
27 100.0%
|
|
| Male |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
|
Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 0 participants | 0 participants | 0 participants | |
| 0 | ||||
|
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
|
||||
|
Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
||||
| United States | Number Analyzed | 22 participants | 5 participants | 27 participants |
|
22 100.0%
|
5 100.0%
|
27 100.0%
|
||
|
Endometrial Thickness
Mean (Standard Deviation) Unit of measure: Cm |
||||
| Number Analyzed | 22 participants | 5 participants | 27 participants | |
| 6.3 (2.3) | 4.3 (1.2) | 5.9 (2.3) | ||
|
Ashermans score on hysteroscopy
[1] [2] Mean (Standard Deviation) Unit of measure: Score |
||||
| Number Analyzed | 8 participants | 5 participants | 13 participants | |
| 5.6 (1.17) | 5.8 (2.49) | 5.67 (1.63) | ||
|
[1]
Measure Description: The American Fertility Society (presently ASRM) developed a classification system upon hysteroscopic assessment of intrauterine adhesions. Parameters assessed are: extent of cavity involved (<1/3, 1/3-2/3 an >2/3, with scores 1, 2, 4 respectively), type of adhesions (filmy, filmy and dense and dense, with scores 1, 2, 4 respectively), menstrual pattern (normal, hypomenorrhea, amenorrhea, with scores 0, 2, 4 respectively). Then overall severity of intrauterine adhesive disease is expressed as a total: stage 1 (mild) - score 1-4, Stage II (moderate (score 5-8), Stage III (severe)- score 9-12.
[2]
Measure Analysis Population Description: This score was only calculated for patients with ashermans syndrome who had hysteroscopy in the randomized trial portion of the study.
|
||||
Outcome Measures
Adverse Events
Limitations and Caveats
The study was a pilot study and was not adequately powered to detect a difference. In addition the study was closed prior to full enrollment.
More Information
Results Point of Contact
| Name/Title: | Heather Huddleston |
| Organization: | UCSF |
| Phone: | 415-353-3040 |
| EMail: | heather.huddleston@ucsf.edu |
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT02825849 |
| Other Study ID Numbers: |
16-19764 |
| First Submitted: | July 3, 2016 |
| First Posted: | July 7, 2016 |
| Results First Submitted: | December 2, 2020 |
| Results First Posted: | February 9, 2021 |
| Last Update Posted: | February 9, 2021 |