RecruitingNAINTERVENTIONAL

Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

This study is investigating a technique called ovarian tissue autograft. This is where ovarian tissue that was frozen earlier is re-implanted into a woman's body. This treatment is offered to women whose ovaries stopped working prematurely, often due to medical treatments like chemotherapy. The main goals are to see how well this re-implanted tissue helps the ovaries start working normally again and if it leads to successful pregnancies and live births. Researchers will also closely follow patients who have had their ovarian tissue frozen and those who have had it re-implanted. For women who had cancer, the study also checks the tissue very carefully to make sure there's no risk of cancer coming back.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

Start

01 Oct 2013

Estimated completion

31 Dec 2024

Ovarian Function Insufficiency

What is this study about?

This study is about a special procedure called ovarian tissue 'autograft'. You can think of an autograft as a self-transplant – it means your own tissue is put back into your body. In this case, doctors take a small piece of ovarian tissue from a woman and freeze it. This is often done before treatments like chemotherapy or radiotherapy that might harm her ovaries and stop her from having children in the future. When she's ready, and if her ovaries are not working, that frozen tissue can be thawed and put back into her body.

The main aim of this study is to understand how well this procedure works. Researchers want to see if putting the tissue back helps the ovaries start producing hormones and eggs again, naturally restarting a woman's fertility. They are particularly interested in whether women can become pregnant and have healthy babies after this procedure. This research is important because it helps improve fertility options for women who might otherwise lose their chance to have children due to other medical treatments.

The study also involves carefully checking the frozen ovarian tissue for any signs of disease, especially in women who had cancer, to make sure it's completely safe before being put back into the body. By collecting detailed information from women who have had this procedure, the researchers hope to make it even more successful and understand the long-term effects.

Key takeaways

This study focuses on restoring fertility using a woman's own frozen ovarian tissue.
It aims to see how well this 'autograft' procedure helps ovaries work normally and leads to live births.
Participants are women aged 18-43 who have already had their ovarian tissue frozen and re-implanted.
The research helps improve options for women who risked losing their fertility due to other medical treatments.
Tissue is carefully screened for safety, especially in women with a history of cancer.

Who may be eligible?

This study is looking for women between 18 and 43 years old. To take part, you must have previously had some of your ovarian tissue frozen because there was a risk your fertility would be affected. You should also have experienced early menopause or your ovaries stopping working too soon, and have already received the ovarian tissue re-implantation treatment. Importantly, you must have fully recovered from any previous serious illness you had.

There are a few reasons why you might not be able to join the study. These include if you have a legal guardian or someone who manages your affairs for you, as this study requires you to be able to give your full consent on your own behalf.

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 between 18 and 43 years old?
Have you had some of your ovarian tissue frozen in the past?
Have you already had this frozen ovarian tissue re-implanted?
Have your ovaries stopped working too soon or prematurely?
Are you fully recovered from any previous serious illness?
Are you able to make your own medical decisions?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the researchers will collect information about your medical history and the results of your ovarian tissue freezing and re-implantation. They will monitor your ovarian function, meaning how well your ovaries are working, and check for any signs of pregnancy or live births after the treatment. You will have regular follow-up appointments, which will involve tests and discussions with the study team. The total duration of your participation will depend on the monitoring schedule, which can continue for several years to track long-term outcomes and any pregnancies.

Potential risks and benefits

The main benefit of this treatment and being part of this study is the potential to regain your fertility and have children, which might not have been possible otherwise. Potential risks related to the re-implantation procedure can include minor surgical risks like infection or bleeding, though these are rare. There's also the very small theoretical risk, if you had a gynaecological cancer, that cancer cells could be reintroduced, but the tissue is carefully screened to minimise this. You are always free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

CHRU Besancon
Verified postcode
Besançon, France· Recruiting

Common questions

What is 'ovarian tissue autograft'?

It's a procedure where a piece of your own frozen ovarian tissue is put back into your body to try and restore your fertility.

Why would someone need this treatment?

Often, it's for women whose ovaries stopped working too early, sometimes because of strong medical treatments like chemotherapy for cancer.

Will this guarantee I can have a baby?

While it aims to restore fertility, success isn't guaranteed. This study is helping us understand how effective it is.

Is it safe if I had cancer previously?

Yes, the tissue is very carefully checked for any remaining cancer cells before it's put back, to keep you safe.

What will happen during the study?

Researchers will collect your medical information and monitor your ovarian function and any pregnancies over time.

How to find out more

Clotilde AMIOT, MD PhD

clotilde.amiot@univ-fcomte.fr +33381218681 Official trial record

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