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NCT Number: NCT07119060

Ablative Technique For Ovarian Preservation In Endometrioma

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

Recruiting

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Key information

Conditions

Endometrioma Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fertility Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IFEMEndo - Clinique Tivoli

Bordeaux, 33000, France

Location status: Recruiting

Location contact

Adrien CRESTANI

PRINCIPAL_INVESTIGATOR

Benjamin MERLOT

SUB_INVESTIGATOR

Clotilde HUET

CONTACT

[email protected]

+33 7 85 30 63 45

Horace ROMAN

SUB_INVESTIGATOR

Kristina ANANIAN

CONTACT

[email protected]

+33 6 50 13 92 54

Paul Henri GOUALARD

SUB_INVESTIGATOR

Thomas DENNIS

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cystectomy

Procedure

Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique)

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

Primary outcomes

  1. To compare pregnancy rates observed up to 24 months after surgery for endometriosis with endometrioma treatment

    Time frame: 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 outcomes

  1. To compare birth rates pregnancies

    Time frame: From enrollment to 24 months after the surgery

  2. To compare spontaneous pregnancy rates

    Time frame: From enrollment to 24 months after the surgery

  3. To compare pregnancies achieved through assisted reproductive technology (ART)

    Time frame: From enrollment to 24 months after the surgery

  4. To compare pregnancies progressing beyond 12 weeks of amenorrhea

    Time frame: From enrollment to 24 months after the surgery

  5. To compare the recurrence rate of endometriomas, defined as the appearance of an endometrioma larger than 2 cm on the same ovary.

    Time frame: From enrollment to 24 months after the surgery

  6. To compare postoperative complication rates

    Time frame: During 3 months after the surgery

  7. To compare pain scores using the Biberoglu and Behrman scale (Biberoglu and Behrman >4)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clotilde HUET

CONTACT

[email protected]

+33 7 85 30 63 45

Kristina ANANIAN

CONTACT

[email protected]

+33 6 50 13 92 54

Sponsors and collaborators

Lead sponsor

Clinique Tivoli Ducos

Other

Registry information

Official study title

Monocentric, Controlled, Randomized Trial: Comparison of Pregnancy Rates in Women With One or More Endometriomas, Treated by Cystectomy, Plasma Vaporization, or Sclerotherapy

Acronym: ATOPE

Important dates

Study start
2025
Primary completion
2034
Study completion
2035
First posted
Aug 12, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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