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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01400-47 | Other Identifier | ANSM |
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The goal of this clinical trial is to compare pregnancy rates after different surgical treatments for endometriomas in adult women who have one or more ovarian cysts (endometriomas) larger than 2 cm requiring surgery. The main questions it aims to answer are:
How many women become pregnant within 24 months after surgery ? What are the birth rates and different types of pregnancies (natural, with fertility treatments, and those continuing beyond 12 weeks)? How often do the endometriomas come back after surgery? What surgery-related complications occur? How do pain levels change after treatment?
Researchers will compare different surgical treatment groups to see if one approach results in better pregnancy outcomes and fewer complications.
Participants will:
Be randomly assigned to different surgical treatment groups Undergo surgery for their endometriomas and endometriosis Attend follow-up visits at 3 months and 24 months after the procedure Have their pregnancy outcomes, pain levels, and potential complications monitored throughout the study period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cystectomy | Experimental | Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique) |
|
| vaporization with plasma | Active Comparator | It consists of destroying the cyst wall (vaporization) using plasma energy. |
|
| sclerotherapy | Other | Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% ethanol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cystectomy | Procedure | Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare pregnancy rates observed up to 24 months after surgery for endometriosis with endometrioma treatment | A Pregnancy is considered if the CGH is >1000 UI/L or a intra uterine pregnancy after 5 weeks of amenorrhea | From enrollment to 24 months after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| To compare birth rates pregnancies | From enrollment to 24 months after the surgery | |
| To compare spontaneous pregnancy rates | From enrollment to 24 months after the surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clotilde HUET | Contact | +33 7 85 30 63 45 | recherche@ifemendo.fr | |
| Kristina ANANIAN | Contact | +33 6 50 13 92 54 | arc@ifemendo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Horace ROMAN | IFEMEndo - Clinique Tivoli | Study Director |
| Adrien CRESTANI | IFEMEndo - Clinique Tivoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IFEMEndo - Clinique Tivoli | Recruiting | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42049313 | Derived | Crestani A, Merlot B, Chanavaz Lacheray I, Dennis T, Goualard PH, Roman H. ATOPE study protocol: a randomised controlled trial comparing cystectomy and plasma vapourisation in endometriomas under 6 cm, with an observational arm for sclerotherapy in larger cysts. BMJ Open. 2026 Apr 28;16(4):e112291. doi: 10.1136/bmjopen-2025-112291. |
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IPD that underlie the results reported in this study (after de-identification) will be shared.
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The data will be available beginning 12 months after publication of the primary results, for a period of 3 years.
Data will be shared with researchers who provide a methodologically sound proposal and whose aims are compatible with the original study objectives
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015653 | Cystectomy |
| D015911 | Sclerotherapy |
| ID | Term |
|---|---|
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D004358 | Drug Therapy |
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| plasma vaporization | Procedure | It consists of destroying the cyst wall (vaporization) using plasma energy |
|
| Sclerotherapy | Procedure | Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% alcohol |
|
| To compare pregnancies achieved through assisted reproductive technology (ART) |
| From enrollment to 24 months after the surgery |
| To compare pregnancies progressing beyond 12 weeks of amenorrhea | From enrollment to 24 months after the surgery |
| To compare the recurrence rate of endometriomas, defined as the appearance of an endometrioma larger than 2 cm on the same ovary. | From enrollment to 24 months after the surgery |
| To compare postoperative complication rates | During 3 months after the surgery |
| To compare pain scores using the Biberoglu and Behrman scale (Biberoglu and Behrman >4) | Pelvic pain will be assessed using the Biberoglu and Behrman scale, which evaluates pain in three domains: dysmenorrhea, dyspareunia, and pelvic pain on palpation. Each domain is scored from 0 (no pain) to 3 (severe pain), with a total score ranging from 0 to 9. Higher scores indicate more severe pain (i.e., a worse outcome). A score greater than 4 is considered clinically significant. | From enrollment to 24 months after the surgery |
| D000091662 | Genital Diseases |
| D013812 | Therapeutics |