Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
This study, taking place in Germany, is for women aged 18 to 40 who need surgery for ovarian endometriomas, which are cysts caused by endometriosis. It aims to compare two different surgical methods: a standard procedure called cystectomy and a newer one using argon plasma. Researchers want to understand how each treatment affects a woman's ovarian reserve, which is like her egg count, by measuring hormone levels before and after the surgery. Seventy-two patients will be randomly assigned to receive one of the two treatments. Regular follow-up appointments will check their progress over a year. The goal is to find out which treatment might be better at preserving future fertility.
At a glance
What is this study about?
This research study is looking into the best way to treat ovarian endometriomas. These are cysts that can form on the ovaries in women who have endometriosis. Endometriosis is a common condition where tissue similar to the lining of the womb grows outside of it, often causing pain and sometimes affecting fertility.
The main aim of this study is to compare two surgical methods for treating these cysts: a "standard cystectomy" (which is a common way to remove the cyst) and a newer method called "argon plasma coagulation" (APC). The researchers want to find out if one method is better than the other at protecting a woman's ovarian reserve. Your ovarian reserve is essentially an indicator of how many eggs you have left, which is important if you're thinking about future pregnancies. They will measure a hormone called AMH in your blood, which gives an idea of your ovarian reserve.
Seventy-two women will take part in this study in Germany. If you join, you'll be randomly chosen to receive either the standard surgery or the APC treatment. There's a 50/50 chance of getting either. The study will carefully track changes in your AMH levels for a year after surgery to see how each treatment affects your egg count. This research is important because it could help doctors understand which surgical option is best for women with ovarian endometriomas, especially those concerned about their fertility.
Key takeaways
- Compares two surgical treatments for ovarian endometriomas.
- Aims to see how each surgery affects a woman's egg count (ovarian reserve).
- For women aged 18-40 needing surgery for these cysts.
- Participation involves surgery and follow-up appointments over one year.
- You'll be randomly assigned to one of the two treatments.
- The study takes place in Tuebingen, Germany.
Who may be eligible?
To be considered for this study, you would need to be a woman between the ages of 18 and 40 who needs surgery for an ovarian endometrioma based on your symptoms. You also need to be able to understand the study and agree to take part by signing a consent form.
There are some reasons why you wouldn't be able to join. For example, if you've already had surgery on your ovaries before, or if you have endometriomas that have come back on your ovaries after previous treatment, you wouldn't be suitable. However, if you have other types of endometriosis that have come back elsewhere, you might still be able to join. Also, if you are pregnant or breastfeeding, or if you are already taking part in another study that could affect your AMH levels (the hormone they are measuring), you wouldn't be eligible. Lastly, if there's a reason the researchers think you might not be able to complete all parts of the study, you wouldn'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.
- Are you a woman between 18 and 40 years old?
- Do you need surgery for an ovarian endometrioma?
- Have you NOT had previous surgery on your ovaries?
- Are you NOT pregnant or breastfeeding?
- Are you NOT already in another study that could affect your hormone levels?
What does participation involve?
If you decide to take part in this study, you'll have several appointments over about a year. Your first visit (Visit 1) is for screening, where they'll check if you meet all the study requirements. After that, at Visit 2, you'll have the surgery itself, where you'll receive either the standard cystectomy or the argon plasma treatment for your ovarian endometrioma. Any other endometriosis found will be treated with the standard surgical approach.
You'll then have follow-up visits. Visits 3 and 4 will be at the study site after three and six months, respectively, where they will check your progress and measure your AMH levels. Your final follow-up, Visit 5, will happen after twelve months and will be a phone call instead of a clinic visit. The total duration of your active participation, from screening to the final phone call, will be about one year.
Potential risks and benefits
Locations (1)
- Department for Women's HealthVerified postcodeTübingen, Germany· Recruiting
Common questions
What is an ovarian endometrioma?
It's a type of cyst that forms on the ovary due to endometriosis, a condition where tissue similar to the womb lining grows outside the womb.
What is AMH and why are they measuring it?
AMH (Anti-Müllerian Hormone) is a hormone in your blood that tells doctors about your ovarian reserve, meaning how many eggs you have. They're measuring it to see how surgery affects your potential for future pregnancies.
Will I get to choose which surgery I have?
No, you will be randomly assigned to either the standard surgery or the argon plasma treatment. There's a 50/50 chance of getting either.
Where is this study taking place?
This study is being conducted at the Department for Women's Health in Tuebingen, Germany.
How many visits will I need to attend?
You will have two in-person visits before surgery, plus two more in-person follow-up visits, and one final follow-up over the phone, totalling five contacts over a year.
How to find out more
Vanessa Steinmetz
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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