AuthorisedTherapeutic confirmatory (Phase III)Interventional

Immunomodulatory therapy to restore ovarian function and improve fertility in women with autoimmune premature ovarian insufficiency – a double-blind, placebo-controlled, randomized study

This research is investigating a new treatment for women with autoimmune premature ovarian insufficiency. This condition means the ovaries stop working properly much earlier than expected due to the body's immune system attacking them. The study uses a medicine called rituximab to see if it can help reactivate the ovaries. We're comparing rituximab to a placebo (a dummy medicine) to understand if it can help women produce eggs again, which is important for fertility. We'll also be checking for other signs that the ovaries are improving, like natural periods and hormone changes, and carefully monitoring participant safety throughout the study. This is a Phase III study, meaning it's a later stage of research aiming to confirm if the treatment is effective and safe.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Karolinska University Hospital

Enrolment target

Start

17 Oct 2025

Autoimmune Premature Ovarian Insufficiency

What is this study about?

This study is looking into a new way to help women who have a condition called autoimmune premature ovarian insufficiency (POI). If you have POI, it means your ovaries, which usually produce eggs and hormones, stop working properly much earlier than they should. This is often because your body's immune system mistakenly attacks them. This can make it very difficult to get pregnant naturally.

The research focuses on a medicine called rituximab. This medicine is designed to calm down the immune system. We want to find out if giving rituximab can help ‘restart’ the ovaries, allowing them to produce eggs again. To measure this, we will see if women can produce eggs after a special treatment that encourages the ovaries to make multiple eggs (called controlled ovarian hyperstimulation). We'll compare women who receive rituximab to those who receive a placebo (a dummy treatment, which looks the same but contains no active medicine). This helps us know if any improvements are genuinely due to the rituximab.

Beyond egg retrieval, we'll also be looking for other important signs of ovarian function improving. This includes whether women start having natural periods again, if their hormone levels (which indicate ovarian activity) change, and how their overall quality of life might be affected. Safety is extremely important, so we will closely watch for any side effects from the medication or the egg stimulation process.

Key takeaways

This study explores a new treatment for autoimmune premature ovarian insufficiency.
It tests a medicine called rituximab against a placebo over 19 months.
The main goal is to see if ovaries can produce eggs again and if periods return.
Researchers will also check hormone levels, quality of life, and safety.
Participation involves medical assessments and potential infusions.
You have the right to leave the study at any time.

Who may be eligible?

This study is for women who have been diagnosed with autoimmune premature ovarian insufficiency. This means your ovaries have stopped working earlier than usual, and doctors believe it's due to your immune system.

You must be at least 18 years old to take part. There isn't an upper age limit mentioned, but the study is focused on ovarian function and fertility, so typically participants would be within their reproductive years.

More specific details about health conditions, past treatments, or other factors might mean you can't join. If you're interested, it's really important to talk to your doctor or the study team to see if you meet all the requirements.

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 diagnosed with autoimmune premature ovarian insufficiency?
Are you 18 years old or older?
Are you interested in a study looking at ovarian function and fertility?
Are you able to commit to 19 months of study visits and assessments?
Are you open to potentially receiving either an active medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the study medicine (rituximab) or a placebo (a dummy treatment). You, and your doctors, would not know which one you are receiving – this is called a 'double-blind' study. The active treatment and placebo would be given as infusions (into a vein) over a period.

Over 19 months, you would have several visits for assessments. Some key steps include a process called 'controlled ovarian hyperstimulation' to encourage your ovaries to produce eggs, and we'll check if eggs can be retrieved after this. We will also monitor your health closely through blood tests to check hormone levels, immune markers, and general safety. You would also complete questionnaires about your quality of life. The study team will explain the full schedule of visits, tests, and how long each part will take.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as the chance that rituximab might help restore your ovarian function and improve your fertility. However, there's no guarantee the treatment will work for you, and you might receive the placebo. All medicines carry potential risks, and rituximab has known side effects, which the study team would explain in detail. There are also risks associated with the controlled ovarian hyperstimulation process. Your safety will be closely monitored throughout the study. You have the right 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
Sweden

Common questions

What is autoimmune premature ovarian insufficiency (POI)?

It's a condition where your ovaries stop working properly too early, often because your body's immune system attacks them, leading to difficulty getting pregnant naturally.

What is rituximab?

Rituximab is a medicine that works by affecting your immune system. In this study, we're seeing if it can help your ovaries start working again.

What does 'double-blind, placebo-controlled' mean?

It means neither you nor your doctors will know if you're getting the active medicine or a dummy treatment (placebo). This helps us get clearer results.

Will I become pregnant if I join this study?

The study aims to see if ovarian function improves and egg retrieval is possible, which is a step towards fertility. It does not guarantee pregnancy.

How long will the study last if I join?

The full study period for each participant is expected to be 19 months.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.