AuthorisedTherapeutic confirmatory (Phase III)Interventional

Impact of Intraovarian Injection of Platelet-Rich Plasma and Growth Factors on IVF Outcomes in Patients with Low Ovarian Reserve: A Randomized Controlled Trial

This research is investigating a new treatment for women who struggle to get pregnant because they have a low number of eggs, often called low ovarian reserve. The study wants to see if injecting a special part of a woman's own blood, called platelet-rich plasma (PRP), along with other helpful substances, directly into the ovaries can improve the chances of collecting more eggs during IVF (In Vitro Fertilisation). Researchers will compare this treatment to a simple dummy injection. This is a large-scale study, aiming to confirm if this new approach is effective and safe to help more women achieve a pregnancy through IVF.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Ivi Alicante S.L.

Enrolment target

160

Start

30 Jul 2025

Female Infertility

What is this study about?

This study is looking into a new way to help women who are having difficulty getting pregnant because they have fewer eggs than expected for their age. This is often called having a 'low ovarian reserve.' When women go through IVF (which stands for In Vitro Fertilisation), doctors try to collect eggs from their ovaries. Having a low ovarian reserve can make it harder to collect enough eggs for IVF to be successful.

The researchers in this study are testing a treatment that involves taking a small amount of a woman's own blood, processing it, and then injecting a special enriched part of it into her ovaries. This part of the blood is called 'platelet-rich plasma' (PRP), and it contains substances that are thought to help cells grow and heal. The idea is that these substances might encourage the ovaries to produce more eggs, or better quality eggs, potentially improving the chances of a successful IVF cycle.

To find out if this treatment really works, the study will compare it to a 'placebo.' A placebo is a dummy treatment, often a salt-water solution, that looks and feels like the real treatment but doesn't contain any active ingredients. This comparison helps doctors understand if any changes seen are due to the actual treatment or other factors. This type of study, called a Phase III trial, is a crucial step to see if a new treatment is effective and safe enough to be widely used.

Key takeaways

This study evaluates a new treatment for women with low egg count undergoing IVF.
The treatment involves injecting a special part of your own blood (PRP) into the ovaries.
The aim is to see if this treatment can increase the number of eggs collected during IVF.
Participants will be randomly assigned to either the PRP treatment or a dummy injection.
This is a Phase III study, designed to confirm if the treatment is effective and safe.

Who may be eligible?

This study is specifically for women who are struggling to get pregnant. You would need to be an adult, 18 years old or older, with no upper age limit specified, meaning older women with this condition might also be considered.

The main focus is on women who have been diagnosed with a 'low ovarian reserve.' This means that tests have shown you have a lower number of eggs available in your ovaries than is typical for your age. This condition is a key reason for taking part in this particular research.

Your doctors will do several checks to make sure this study is the right fit for you and that you meet all the specific requirements. They will explain everything clearly if you are interested in joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or over?
Have you been diagnosed with 'low ovarian reserve'?
Are you planning to undergo IVF treatment?
Are you able to attend all required clinic appointments?
Are you willing for your treatment to be decided by chance (randomly assigned)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of tests to confirm you meet all the entry requirements. If you're eligible, you would then be randomly assigned to either receive the active treatment (the special blood injection into your ovaries) or a dummy injection. Neither you nor your doctor would know which treatment you are receiving, which helps make the study results fair.

The main procedure involves an injection into your ovaries. This is usually done with a needle guided by ultrasound, similar to how eggs are collected during IVF. After the injection, you would go through your regular IVF treatment. The doctors would then specifically look at how many eggs they are able to collect from you during that IVF cycle.

You would have regular appointments and tests as part of your IVF journey, and the study team would collect information at these points. The total time you would be involved in the study would depend on your IVF cycle, for example, from the point of injection until your egg collection. All procedures, visits, and follow-ups would be explained in detail before you agree to participate.

Potential risks and benefits

Taking part in this study may offer the potential benefit of improving the number of eggs collected during your IVF cycle, which could increase your chances of becoming pregnant, although this is not guaranteed. However, as with any medical procedure, there are potential risks, including those associated with the ovarian injection, such as discomfort, infection, or bleeding. There may also be no benefit at all from the treatment. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is 'low ovarian reserve'?

Low ovarian reserve means you have fewer eggs in your ovaries than expected for your age, which can make it harder to get pregnant naturally or with IVF.

What is PRP?

PRP stands for Platelet-Rich Plasma. It's a part of your own blood that's been specially prepared to have a higher concentration of 'growth factors' – substances that can help cells grow and heal.

Will I definitely get the active treatment?

No, you will be randomly assigned to either receive the active treatment or a dummy injection (placebo). This helps compare the treatments fairly. Neither you nor your doctor will know which one you receive.

What is a 'dummy injection'?

A dummy injection, or placebo, is a salt-water solution that looks and feels like the real treatment but doesn't contain any active medicine. It helps researchers see if the real treatment is actually working.

How long will I be in the study?

The duration of your participation will mainly cover your IVF cycle, from the time of the injection until your egg collection, with follow-up appointments as needed by the study doctors.