RecruitingNAINTERVENTIONAL

Ablative Technique For Ovarian Preservation In Endometrioma

This study is investigating different surgical treatments for ovarian cysts called endometriomas, which are linked to endometriosis. The main goal is to compare how successful these surgeries are in helping women aged 18 to 43 get pregnant within two years. Researchers also want to see how often these cysts come back and what complications might occur after each type of surgery. Women taking part will be assigned to a surgical group, have their operation, and then undergo follow-up appointments. By comparing the outcomes, the study hopes to find the best way to treat endometriomas while also protecting a woman's ability to have children and improving their pain.

At a glance

Status

Recruiting

Phase

Sponsor

Clinique Tivoli Ducos

Enrolment target

332

Start

18 Sep 2025

Estimated completion

01 Jan 2035

Endometrioma Fertility

What is this study about?

Endometriomas are types of cysts that can grow on your ovaries if you have endometriosis. These cysts can sometimes cause pain and might affect your ability to get pregnant. If you have an endometrioma larger than 2 centimetres that needs surgery, this study could be for you. The researchers want to find the best way to remove these cysts while hopefully making it easier for you to conceive a baby and reducing your pain.

The study will look at different surgical methods. Some women might have a surgery called a 'cystectomy', others might have 'plasma vaporization', and some might have 'sclerotherapy'. These are all ways to remove or treat the cysts. The important thing is that the study will compare these methods to see which one leads to the highest pregnancy rates, the lowest chance of the cysts returning, and the fewest side effects.

By taking part, you would help doctors understand which surgical approach works best for women like you. The aim is to improve future treatments so that women with endometriomas have the best possible chance of becoming pregnant and living without pain.

Key takeaways

This study compares different surgeries for ovarian cysts (endometriomas).
It aims to find the best surgery for fertility, pain, and preventing cysts from returning.
Participants must be women aged 18-43 with specific endometriosis symptoms and ovarian cysts.
You would be randomly assigned to a surgery group and followed for two years.
Your pregnancy outcomes, pain, and any complications will be monitored.

Who may be eligible?

To be able to join this study, you need to be a woman between 18 and 43 years old. You must have been diagnosed with endometriosis, either through examinations or scans, and be experiencing symptoms like pelvic pain or problems getting pregnant, or if the endometriosis is posing a risk to an organ. You should also have at least one ovarian cyst (an endometrioma) on your ovary that is larger than 2 centimetres, as shown on a scan within the last year.

It's important that you have a clear intention to try and get pregnant after the surgery. You'll also need to understand the study well and agree to take part by signing a consent form. You'll also need to be covered by a social security scheme, which most people in the UK are through the NHS system.

You cannot participate if the doctors find during surgery that your cyst isn't actually an endometrioma. Other reasons you couldn't take part include being pregnant or breastfeeding, if you have a legal guardian or can't give consent, or if you don't understand French well enough (as this study may have French-speaking participants or researchers).

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 between 18 and 43 years old?
Have you been diagnosed with endometriosis and have symptoms needing surgery?
Do you have an ovarian cyst (endometrioma) larger than 2cm that needs surgery?
Do you intend to try and get pregnant after your surgery?
Are you able to provide your informed consent to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first sign a consent form after having all your questions answered. You would then be randomly assigned to one of the different surgical treatment groups for your endometrioma. This means a computer or similar method would decide which surgical technique you receive, not you or your doctor.

After your surgery for the endometriomas (and any other endometriosis found), you would have follow-up appointments. These would happen at 3 months and again at 24 months (2 years) after your operation. During these appointments, the study team would check on your pregnancy outcomes, how your pain levels have changed, and if you've experienced any complications after the surgery. The study would last for 24 months after your surgery.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as contributing valuable information that could improve future treatments for endometriomas, and you would receive close monitoring of your health after surgery. However, as with any surgery, there are potential risks, including side effects from the operation itself or the possibility that the treatment may not be completely successful. You would be fully informed of all risks associated with your specific surgical procedure by your medical team. It's important to know that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

IFEMEndo - Clinique Tivoli
Verified postcode
Bordeaux, France· Recruiting

Common questions

What is an endometrioma?

An endometrioma is a type of cyst that can form on your ovaries if you have endometriosis.

What does 'randomly assigned' mean?

It means you'd be put into one of the surgery groups by chance, like drawing numbers from a hat, rather than you or your doctor choosing.

Will I know which surgery I'm getting?

Yes, you would know which surgical technique you're assigned to before your operation.

How long will I be followed in the study?

You would be followed for 24 months (2 years) after your surgery.

What kind of follow-up will I have?

You'll have appointments at 3 and 24 months after surgery to check on your health, pain, and if you've become pregnant.

How to find out more

Clotilde HUET

recherche@ifemendo.fr +33 7 85 30 63 45 Official trial record

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