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Study of Platelet-Rich Plasma and Growth Factors Given by Ovarian Injection to Women with Low Ovarian Reserve During IVF Treatment

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What is this trial about?

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

This study focuses on women with female infertility, specifically those with low ovarian reserve. The research examines the effectiveness of platelet-rich plasma with growth factors (PRGF-Endoret®) compared to placebo in improving outcomes during in vitro fertilization (IVF) treatment. Platelet-rich plasma is a concentrated portion of blood that contains special proteins that help with healing and tissue growth.

The treatment involves an intraovarian injection (injection directly into the ovary) of either platelet-rich plasma with growth factors or a placebo consisting of sodium chloride solution (salt water). The main purpose is to determine if this treatment can increase the number of eggs retrieved during the IVF procedure in women with reduced ovarian function.

During the study, participants will undergo one IVF cycle where they will receive a single injection of either the study treatment or placebo. The maximum amount of solution injected will be 6 milliliters, and the treatment will be administered through a standard injection procedure. The study will measure how many eggs can be collected following the treatment.

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

    Initial preparation

    Your blood test results must be valid (not older than 6 months), including platelet count above 160,000/mcL

    Recent test results (less than 3 months old) must show negative results for HIV, HCV, HBV and RPR

  2. Step 2

    Treatment group assignment

    You will be randomly assigned to receive either PRGF Endoret® or placebo treatment

    The treatment will be administered through an intraovarian injection (injection into the ovary)

  3. Step 3

    Treatment administration

    The procedure involves an injection of either platelet concentrate solution or saline solution

    The injection will be performed through a vaginal approach to reach both ovaries

  4. Step 4

    IVF procedure

    You will undergo a single IVF (In Vitro Fertilization) cycle

    The medical team will retrieve and count the eggs produced after the treatment

  5. Step 5

    Follow-up

    The primary focus will be on measuring the number of eggs retrieved after the treatment

    The study will continue until April 30, 2027

Who can join the trial?

13 criteria

  • Women diagnosed with low ovarian response (a condition where ovaries produce fewer eggs than expected)
  • Age between 18 and 42 years
  • Regular menstrual cycles occurring every 24 to 35 days
  • Participating in a single IVF (In Vitro Fertilization) cycle without storing additional eggs or embryos
  • Both partners must have normal karyotypes (normal chromosome structure)
  • Recent blood work (within 6 months) showing platelet count above 160,000/mcL (platelets are blood cells that help with clotting)
  • Negative test results (less than 3 months old) for:
    • HIV (Human Immunodeficiency Virus)
    • HCV (Hepatitis C Virus)
    • HBV (Hepatitis B Virus)
    • RPR (test for syphilis)
    • Partner must have sperm count greater than 5 million motile sperm per sample, or using sperm donation
    • Both ovaries must be accessible for vaginal ultrasound
    • BMI (Body Mass Index) must be above 18 kg/m2

Who cannot join the trial?

14 criteria

  • Age less than 18 or over 40 years
  • Male patients (study is for females only)
  • Currently pregnant or breastfeeding
  • Known allergic reactions to blood products
  • Active infections or inflammatory conditions
  • History of ovarian surgery or removal
  • Presence of ovarian cysts larger than 3 cm
  • Current use of medications that could interfere with fertility treatment
  • Uncontrolled medical conditions like diabetes or thyroid disorders
  • Body Mass Index (BMI) over 35 (a measure of body fat based on height and weight)
  • Previous unsuccessful in vitro fertilization (process where eggs are fertilized outside the body) attempts more than 3 times
  • Active substance abuse or smoking
  • Mental health conditions that could affect ability to follow study procedures
  • Participation in other clinical trials within the past 3 months
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Investigated drugs

PRFG-Endoret is a specialized preparation made from the patient's own blood. It contains concentrated platelets and growth factors that are injected directly into the ovaries. This treatment is designed to potentially improve ovarian function in women with low ovarian reserve during IVF treatment. The platelets and growth factors in this preparation are believed to help stimulate and regenerate ovarian tissue, which may lead to better egg production during fertility treatments.

What is already known about the treatment

PRFG-Endoret - A specialized biological preparation containing concentrated platelet-rich plasma and growth factors, administered through intraovarian injection during fertility treatments. This innovative therapy is currently being investigated in clinical trials for treating female infertility, particularly in patients with low ovarian reserve, where it aims to improve ovarian function and increase the number of viable oocytes during IVF procedures. The preparation works by delivering concentrated growth factors and bioactive proteins directly to ovarian tissue, potentially stimulating cellular regeneration and improving ovarian response to fertility treatments. This treatment belongs to the category of autologous cell therapy products and represents an emerging approach in reproductive medicine.

Investigated diseases

Female Infertility - A reproductive condition where a woman is unable to achieve pregnancy after 12 months or more of regular unprotected sexual intercourse. The condition can be caused by various factors affecting the reproductive system, including problems with ovulation, damaged fallopian tubes, or issues with the uterus. Female infertility may be related to age, hormonal imbalances, or structural problems in the reproductive organs. Some women with this condition may still produce eggs but have difficulty with other aspects of conception. The condition can affect women of any age during their reproductive years.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517726-26-00Estimated enrolment160 patientsSponsorIvi Alicante S.L.

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