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Study on the Safety and Effectiveness of Platelet Concentrate for Women with Low Ovarian Reserve

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Low Ovarian Reserve, which affects some women's ability to conceive. The treatment being tested is called Plasma Rich in Growth Factors, also known as Platelet Rich Plasma Human. This treatment involves using a special preparation made from blood components, which is injected into the ovaries to potentially improve their function.

The purpose of the study is to evaluate the safety and effectiveness of this treatment in women with low ovarian reserve. Participants will receive injections of the plasma rich in growth factors, and their ovarian function will be monitored before and after the treatment. This includes checking various markers of ovarian health and observing the outcomes of any fertility treatments they may undergo, such as in vitro fertilization (IVF).

Throughout the study, researchers will compare the participants' ovarian health markers and fertility treatment results before and after receiving the plasma injections. This will help determine if the treatment can improve the chances of pregnancy and the quality of embryos. The study will also track any complications related to pregnancy that may arise after the treatment. The trial is expected to continue until 2026, providing valuable insights into the potential benefits of this innovative approach for women with low ovarian reserve.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that all eligibility criteria are met. This includes being a woman classified in group 3 or 4 of the POSEIDON classification for low ovarian reserve, having at least one ovary, experiencing infertility for at least one year, and providing written consent to participate.

  2. Step 2

    Initial assessment

    Undergo an initial assessment to evaluate ovarian reserve markers. This involves measuring levels of hormones such as FSH (follicle-stimulating hormone), LH (luteinizing hormone), estradiol, and AMH (anti-Müllerian hormone), as well as assessing the antral follicle count (AFC).

  3. Step 3

    Treatment administration

    Receive an injection of plasma rich in growth factors (PRGF) directly into the ovaries. This is an injectable treatment designed to potentially improve ovarian function.

  4. Step 4

    Follow-up assessments

    Participate in follow-up assessments to compare ovarian reserve markers before and after the treatment. This includes re-evaluating hormone levels and the antral follicle count.

    Additional assessments will be conducted in the IVF-ICSI laboratory to monitor the number of oocytes (eggs) recovered, fertilized, and the quality of embryos achieved.

  5. Step 5

    Monitoring outcomes

    Monitor outcomes related to pregnancy rates and any complications that may arise. This includes tracking the number of pregnancies per cycle, the number of embryos transferred, and any pregnancy-related complications such as twin pregnancies or infections.

Who can join the trial?

6 criteria

  • Women who are classified in group 3 or 4 of the POSEIDON classification for low ovarian reserve:
    • POSEIDON 3: Women under 35 years old with low ovarian reserve, which means having an Anti-Müllerian Hormone (AMH) level less than 1.2 ng/ml and an Antral Follicle Count (AFC) less than 5.
    • POSEIDON 4: Women 35 years or older with low ovarian reserve, with the same AMH and AFC levels as above.
    • Women who have at least one ovary.
    • Women who have been experiencing infertility for at least one year. Infertility means not being able to get pregnant after trying for a long time.
    • Women who are expected to have safe access to their ovaries on the day of the procedure.
    • Women who agree to participate in the study and provide their written consent, which means they sign a document agreeing to join the study.

Who cannot join the trial?

3 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you meet the age criteria.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

Factor-Rich Plasma is a therapy used in this clinical trial. It involves using a part of your own blood that is rich in growth factors. These growth factors are special proteins that can help heal and regenerate tissues. In this study, the plasma is injected into the ovaries to see if it can improve the function of the ovaries in women who have a low ovarian reserve. This means that the therapy aims to help the ovaries work better and possibly improve the chances of getting pregnant through assisted reproductive techniques like IVF (In Vitro Fertilization) or ICSI (Intracytoplasmic Sperm Injection).

What is already known about the treatment

Factor-Rich Plasma Intraovarian Growth – This treatment involves the administration of plasma rich in growth factors directly into the ovaries, a method known as intraovarian infusion. It is currently being studied in clinical trials to assess its safety and effectiveness, particularly for women with low ovarian reserve, a condition where the ovaries have fewer eggs than normal. The main goal is to improve markers of ovarian reserve and outcomes in IVF-ICSI procedures. At the molecular level, the growth factors in the plasma are believed to stimulate ovarian cells, potentially enhancing their function and improving fertility outcomes. This treatment falls under the category of regenerative medicine, which focuses on repairing or regenerating damaged tissues.

Investigated diseases

Low Ovarian Reserve – Low Ovarian Reserve is a condition where the ovaries have a reduced number of eggs available for fertilization. This condition can lead to difficulties in conceiving naturally due to the limited availability of viable eggs. As women age, the number of eggs naturally decreases, but in some cases, this decline happens more rapidly. The progression of Low Ovarian Reserve can vary, with some women experiencing a gradual decrease in fertility over time. Hormonal changes, such as alterations in levels of follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH), are often associated with this condition. The condition may also affect the quality of the eggs, further impacting fertility.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514444-87-00Protocol codeURA-PRGF-01Estimated enrolment50 patientsSponsorInstituto De Investigacion Sanitaria Fundacion Jimenez Diaz

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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