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NCT Number: NCT07514234

Optimal Allogeneic PRP Concentration for Oocyte In Vitro Maturation in Women With PCOS

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.

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Key information

Conditions

PCOS (Polycystic Ovary Syndrome) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

30 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sardjito General Hospital

Yogyakarta, Special Region of Yogyakarta, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP plasma rich platelets

Other

An initial pilot experiment tested three different concentrations of PRP supplementation (5%, 25%, and 50%)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

Optimal Allogenic Platelet-rich Plasma Concentration to Improves in Vitro Maturation of Germinal Vesicle Oocytes From Women With PCOS: A Prospective Cohort Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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