- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514234
Optimal Allogeneic PRP Concentration for Oocyte In Vitro Maturation in Women With PCOS
April 1, 2026 updated by: Tiara Kusumaningtyas, Gadjah Mada University
Optimal Allogenic Platelet-rich Plasma Concentration to Improves in Vitro Maturation of Germinal Vesicle Oocytes From Women With PCOS: A Prospective Cohort Study
In vitro maturation is a long-studied technique used to obtain mature oocytes outside the human body.
However, this method can increase the risk of ovarian hyperstimulation syndrome (OHSS), particularly in patients with polycystic ovarian syndrome (PCOS).
Culture media supplemented with platelet-rich plasma (PRP) has previously shown promise for improving oocyte maturation.
This study examined the potential utility of allogeneic PRP supplementation to increase the maturation of germinal vesicle (GV)-stage oocytes collected from PCOS patients who underwent controlled ovarian stimulation.
Supplementation with 5% PRP was found to support oocyte maturation under controlled ovarian stimulation.
Further investigations are required to refine the use of PRP without controlled ovarian stimulation in clinical IVM protocols that may be beneficial for PCOS patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Special Region of Yogyakarta
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Yogyakarta, Special Region of Yogyakarta, Indonesia
- Dr. Sardjito General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Immature oocytes at the germinal vesicle (GV) stage
- Oocytes obtained from patients fulfilling clinical and laboratory diagnostic criteria for PCOS, defined by the presence of at least two of the following three characteristics: clinical hyperandrogenism and/or biochemical hyperandrogenemia, ovulatory dysfunction (oligomenorrhea or anovulation), and polycystic ovarian morphology (≥12 follicles measuring 2-9 mm in each ovary on ultrasonography)
- Oocytes collected from patients undergoing ovarian stimulation using the same ovarian stimulation protocol.
- Oocytes obtained from patients with primary infertility
- Oocytes obtained from treatment-naive patients with PCOS.
Exclusion Criteria:
- Oocytes obtained from patients with comorbid conditions, including cancer, congenital adrenal hyperplasia, Cushing's syndrome, premature ovarian failure (POF) or premature ovarian insufficiency, liver disorders, kidney disease, cardiovascular disease, diabetes mellitus (type 1 or type 2), and patients receiving steroid therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRP plasma rich platelets
An initial pilot experiment tested with PRP supplementation to address oocyte maturation
|
An initial pilot experiment tested three different concentrations of PRP supplementation (5%, 25%, and 50%)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Optimal PRP Concentration
Time Frame: After 24 hours of culture incubation
|
A concentration of 5% PRP was optimal rather than concentrations of 25% and 50% (cells are clumping and also associated with morphological abnormalities, such as cytoplasmic vacuolization, irregular perivitelline space, and abnormal polar bodies)
|
After 24 hours of culture incubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oocyte maturation rate
Time Frame: After 24 hours of culture incubation
|
After optimation, this study used PRP with concentration 5% tu supplementing IVM culture media.
The 5% PRP supplementation group showed a significantly higher rate of oocyte maturation compared to the control group (non-PRP group)
|
After 24 hours of culture incubation
|
|
Oocyte morphological quality and fertilization rate
Time Frame: After 24 hours of culture incubation
|
The PRP 5% group had a higher average TOS than the control group (non-PRP) and the fertilization rate in the PRP 5% group was 80% descriptively
|
After 24 hours of culture incubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Prasath EB. Time line in IVF laboratory. Fertility Science and Research. 2023; 10: 15-19. https://doi.org/10.4103/fsr.fsr_6_23
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2023
Primary Completion (Actual)
September 11, 2023
Study Completion (Actual)
December 9, 2025
Study Registration Dates
First Submitted
March 23, 2026
First Submitted That Met QC Criteria
April 1, 2026
First Posted (Actual)
April 7, 2026
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRP-PCOS-COHORT-UGM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will not be shared due to participant privacy and confidentiality considerations
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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