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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	15.09.2024

Trial locations

Investigated drugs:

Platelet Concentrate

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).

Investigated diseases:

Diminished ovarian reserve

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 ID:

2024-514444-87-00

Protocol code:

URA-PRGF-01

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?