PCOS (Polycystic Ovary Syndrome)NCT07514234
Optimal Allogeneic PRP Concentration for Oocyte In Vitro Maturation in Women With PCOS
A study testing PRP plasma rich platelets in people with PCOS (Polycystic Ovary Syndrome), run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 30 to 41 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- PRP plasma rich platelets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Jan 2023to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Sardjito General Hospital
Yogyakarta, Special Region of Yogyakarta
About this study
Official title: 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.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- PRP plasma rich platelets
- Keywords
- platelet-rich plasma, oocyte maturation, in vitro maturation
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP plasma rich plateletsOther
An initial pilot experiment tested three different concentrations of PRP supplementation (5%, 25%, and 50%)
| Study group | Role | What they receive |
|---|---|---|
| PRP plasma rich platelets | Experimental | An initial pilot experiment tested with PRP supplementation to address oocyte maturation Receives: Other: PRP plasma rich platelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal PRP Concentration
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)
Measured: After 24 hours of culture incubation
Secondary outcomes (2)
Oocyte maturation rate
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)
Measured: After 24 hours of culture incubation
Oocyte morphological quality and fertilization rate
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
Measured: After 24 hours of culture incubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start5 Jan 2023
- Primary completion11 Sep 2023
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study using PRP-supplementation in culture media
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiara Kusumaningtyas, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514234
- Sponsor's protocol ID
- PRP-PCOS-COHORT-UGM
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to participant privacy and confidentiality considerations
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 at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Allogenic Platelet-rich Plasma Concentration to Improves in Vitro Maturation of Germinal Vesicle Oocytes From Women With PCOS: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07514234
- Acronym / sponsor ID
- PRP-PCOS-COHORT-UGM
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Keywords
- platelet-rich plasma, oocyte maturation, in vitro maturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study using PRP-supplementation in culture media
| Arm | Type | Receives |
|---|---|---|
| PRP plasma rich platelets | Experimental | Other: PRP plasma rich plateletsAn initial pilot experiment tested with PRP supplementation to address oocyte maturation |
Who may qualify
- Ages
- 30 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP plasma rich plateletsAn initial pilot experiment tested three different concentrations of PRP supplementation (5%, 25%, and 50%) | Other | PRP plasma rich platelets |
Primary outcome
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)
2 secondary outcomes
Oocyte maturation rate
Time frame: After 24 hours of culture incubation
Oocyte morphological quality and fertilization rate
Time frame: After 24 hours of culture incubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publicationPrasath EB. Time line in IVF laboratory. Fertility Science and Research. 2023; 10: 15-19. https://doi.org/10.4103/fsr.fsr_6_23
- Individual participant dataSharing planned: No. IPD will not be shared due to participant privacy and confidentiality considerations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP plasma rich platelets in people with PCOS (Polycystic Ovary Syndrome), run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal PRP Concentration (time frame: After 24 hours of culture incubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07514234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.