Endometrioma, Fertility
Conditions
Keywords
surgery, endometrioma, endometriosis, kystectomy, sclerotherapy, plasma vaporization, fertility
Brief summary
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
Interventions
PROCEDURECystectomy
Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique)
PROCEDUREplasma vaporization
It consists of destroying the cyst wall (vaporization) using plasma energy
PROCEDURESclerotherapy
Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% alcohol
Sponsors
Clinique Tivoli Ducos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
Inclusion criteria
* Patient aged between 18 and 43 years (inclusive) * Patient diagnosed with endometriosis (by histology or imaging) and symptomatic, requiring surgery (pelvic pain and/or infertility and/or risk to an organ) * Pelvic MRI or ultrasound performed within the last year showing at least one endometrioma larger than 20 mm in diameter * Patient with an intention to conceive (probable or certain) after surgery * Patient informed and having signed the consent form * Patient covered by a social security scheme
Exclusion criteria
* Intraoperative finding that the cyst is not an endometrioma * Patient under guardianship, conservatorship, or incapable of giving consent * Patient without sufficient understanding of the French language * Patient under judicial protection measures * Patient who is pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare pregnancy rates observed up to 24 months after surgery for endometriosis with endometrioma treatment | From enrollment to 24 months after the surgery | A Pregnancy is considered if the CGH is \>1000 UI/L or a intra uterine pregnancy after 5 weeks of amenorrhea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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) | From enrollment to 24 months after the surgery | 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. |
Countries
France
Contacts
CONTACTClotilde HUET
CONTACTKristina ANANIAN
STUDY_DIRECTORHorace ROMAN
IFEMEndo - Clinique Tivoli
PRINCIPAL_INVESTIGATORAdrien CRESTANI
IFEMEndo - Clinique Tivoli
Outcome results
None listed