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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Indonesia
    • Special Region of Yogyakarta
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PRP plasma rich platelets
An initial pilot experiment tested with PRP supplementation to address oocyte maturation
Other: PRP plasma rich platelets
An initial pilot experiment tested three different concentrations of PRP supplementation (5%, 25%, and 50%)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gadjah Mada University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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