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Compares treatment options for Ovarian Endometrioma
Official title Non-inferiority Trial Comparing Vaginal Ultrasound-guided Ethanol Sclerotherapy and Laparoscopic Cystectomy for the Management of Ovarian Endometriomas (E-STEP)
ClinicalTrials.gov ID: NCT07004959
What this study is testing
- What it's testing
- Endometriosis is a disease that affects between 6 and 10% of women of childbearing age. It is defined by the presence of endometrial tissue outside the uterine cavity, most often in the ovaries or the peritoneal cavity.
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Patients aged between 18 and 45
- Endometrioma diagnosed by endovaginal ultrasound or MRI (examinations carried out by a radiologist or gynaecologist) with a typical appearance and...
- Pain (dysmenorrhoea or chronic pelvic pain) with a VAS greater than 30 millimetres, assessed by the question "Indicate the subjective level of your...
You likely can't join if
- Inability to speak French
- Refusal to take part in the study
- Risk factors for impaired ovarian reserve:
- Ovarian reserve already low (AMH \<1,5ng/ml or Antral follicle count \< 7 on the contralateral ovary
- Bilateral or multiple endometriomas (two or more endometriomas greater than 3 centimetres in diameter).
- Previous cystectomy
See the full eligibility criteria
- Patients aged between 18 and 45
- Endometrioma diagnosed by endovaginal ultrasound or MRI (examinations carried out by a radiologist or gynaecologist) with a typical appearance and whose largest diameter is between 3 and 10 centimetres.
- Pain (dysmenorrhoea or chronic pelvic pain) with a VAS greater than 30 millimetres, assessed by the question "Indicate the subjective level of your endometriosis-related pain over the last 4 weeks".
- Inability to speak French
- Refusal to take part in the study
- Risk factors for impaired ovarian reserve:
- Ovarian reserve already low (AMH \<1,5ng/ml or Antral follicle count \< 7 on the contralateral ovary
- Bilateral or multiple endometriomas (two or more endometriomas greater than 3 centimetres in diameter).
- Previous cystectomy
- Previous major peritoneal surgery causing adhesions.
- Contraindication to sclerotherapy : allergy to ethanol
- Contraindications to general anaesthesia
- Pregnant women, women in labour and nursing mothers
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.