RecruitingOBSERVATIONAL

Constitution of a Cohort for Monitoring Patients Candidating for Ovarian Tissue Autograft

This study focuses on women who chose to freeze their ovarian tissue to protect their fertility, often before treatments that might make them infertile. The goal is to create a group of these patients and closely watch what happens when they decide to have this tissue put back into their bodies. This procedure, called an autograft, has led to successful pregnancies in other countries, like France. Researchers want to understand better how effective this technique is for restoring natural ovarian function and helping women become pregnant. They will also look at safety and make sure the process is carefully managed for each patient. It's about helping women use their frozen tissue safely and effectively.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

240

Start

01 May 2013

Estimated completion

01 Oct 2025

Ovarian Function Insufficiency

What is this study about?

Many women go through medical treatments that can affect their ability to have children in the future. To help with this, some choose to freeze a small piece of their ovarian tissue – this is called ovarian cryopreservation. It's a way to save their fertility for later. When they are ready, this frozen tissue can be put back into their body, a procedure called an autograft.

This study aims to create a group of women who have chosen (or might choose) to have their frozen ovarian tissue re-implanted. By carefully following this group over time, doctors can learn more about how well this procedure works. They want to see if it successfully brings back ovarian function, which is the body's natural ability to produce eggs and hormones. This can then potentially allow women to get pregnant naturally.

The study will also help doctors understand the process better, especially when someone with a past illness is considering having their tissue put back. They will check requests for this procedure, and when appropriate, offer it to patients, making sure all safety checks are done. Ultimately, it’s about improving the chances for women to use their frozen ovarian tissue successfully to have a family.

Key takeaways

The study focuses on women who have frozen their ovarian tissue to preserve fertility.
It aims to track how well re-implanting this tissue helps restore ovarian function.
The goal is to understand and improve this fertility-saving technique.
Participants will be closely monitored if they choose to have their tissue re-implanted.
It's open to women aged 11-43 years who meet specific criteria.

Who may be eligible?

This study is looking for women who have already had some of their ovarian tissue frozen for future use. You might be eligible if you've been diagnosed with 'premature ovarian insufficiency,' which means your ovaries aren't working as they should too early in life.

There are also age guidelines. If you are a young person thinking about starting puberty with this treatment, you need to be at least 11 years old (based on your bone age). If you are looking to restore your ovarian function and potentially become pregnant, you should be between 18 and 43 years old.

However, this study isn't suitable for everyone. You cannot join if you are under 11 years old (based on bone age) or if you are older than 43. Also, if you don't want to be part of the study, or if you are an adult under legal guardianship (meaning someone else makes major decisions for you), you won't be able to participate.

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.

Have you had some of your ovarian tissue frozen already?
Are you between 11 and 43 years old?
Do you have 'premature ovarian insufficiency' (for some patients)?
Are you interested in potentially having your frozen tissue put back to restore fertility?
Are you willing for your health to be monitored as part of the study?

Answer every question to see your result.

What does participation involve?

Taking part in this study primarily involves monitoring your health and the use of your frozen ovarian tissue over time. If you decide to have your frozen ovarian tissue put back into your body (an autograft), the study will closely follow how your body responds and if your ovaries start working again. This will likely involve regular check-ups, blood tests to measure hormone levels, and possibly scans to see how your ovaries are functioning. The specific number of visits and assessments will depend on whether you are simply being monitored after freezing your tissue or undergoing the re-implantation procedure and what medical needs arise. The total duration of your participation will vary depending on your individual journey and medical care.

Potential risks and benefits

The main benefit of this study is that it could help more women successfully use their frozen ovarian tissue to restore fertility and potentially have children. For those who undergo the autograft, it offers a pathway to benefiting from this advanced technique. As with any medical procedure, there are potential risks, though not specifically detailed here. These generally relate to surgery (if you have the tissue re-implanted) and the possibility that the ovarian function may not fully return. You will always have the right to withdraw from the study at any time, without it affecting your medical care.

Locations (1)

CHRU Besancon
Verified postcode
Besançon, France· Recruiting

Common questions

What is ovarian tissue cryopreservation?

It's a way of freezing and storing a small piece of your ovarian tissue to preserve your fertility, often before treatments that might cause infertility.

What is an autograft?

An autograft is when your own cryopreserved (frozen) ovarian tissue is put back into your body.

Why is this study happening?

The study wants to learn more about how well putting frozen ovarian tissue back into the body works to restore fertility and help women have babies, and to ensure it's done safely.

Will I get pregnant if I join this study?

This study aims to assess if the procedure helps restore ovarian function, which can lead to pregnancy. However, there's no guarantee of pregnancy. It helps doctors understand the treatment better.

Who can join this study?

Mainly women who have already had their ovarian tissue frozen, are aged between 11-43 years old, and want to understand or use this procedure to restore fertility.

How to find out more

Chlotilde AMIOT, MD, PhD

camiot@chu-besancon.fr Official trial record

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