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NCT Number: NCT07469007

Impact of Surgery for Deep Posterior Endometriosis on Ovarian Reserve (ENDORO)

Endometriosis is a chronic condition typically affecting women of reproductive age and often responsible for chronic pelvic pain and/or infertility.

Its prevalence is estimated at 10% of the female population. Deep endometriosis is a specific phenotype of the disease, defined histologically by infiltration of the peritoneum exceeding 5 mm or by fibromuscular plaques infiltrating the muscularis propria of the abdominopelvic organs. It affects approximately 12 to 20% of patients with endometriosis.

Surgery is one of the treatment options. Its aim is anatomical restoration, notably through complete macroscopic resection of the lesions and the release of adhesions, particularly those affecting the adnexa. While the negative impact of cystectomies on ovarian reserve is well known, the impact of surgery for severe deep endometriosis without ovarian involvement has never been studied. Yet, these procedures are regularly performed, and in the vast majority of cases on women of reproductive age. Moreover, the impression gathered in routine practice suggests a decrease in reserve parameters of around 5%. Therefore, understanding the actual impact of the procedure on ovarian reserve would, if it were concrete, allow for expanding the indications for preoperative fertility preservation to this subgroup of patients.

The main objective is to evaluate the impact of complete macroscopic resection of severe deep posterior pelvic endometriosis on the change in AMH levels at 12 months compared to an unexposed group.

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Key information

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique la croix du sud

Quint-Fonsegrives, 31130, France

Location status: Recruiting

Location contact

Fabien Vidal, Dr

CONTACT

[email protected]

0033609334578

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female, aged 18 to 39 years old;
  • Suspected severe deep posterior pelvic endometriosis on reference pelvic MRI (ovarian kissing, obliteration of the pouch of Douglas) with concordant clinical examination, or confirmed severe deep posterior pelvic endometriosis during exploratory laparoscopy;
  • Patient affiliated with or covered by a social security plan;
  • Patient having been informed and having given her free, informed, and written consent

Exclusion criteria

  • Presence of ovarian involvement defined by the presence of at least one endometrioma >5 mm;
  • History of surgery for severe deep endometriosis;
  • Severe preoperative premature ovarian insufficiency (defined by AMH <1ng/mL and antral follicle count <8);
  • Concurrent use of GnRH agonist therapy at or within the preceding 3 months of enrollment;
  • BMI >35 kg/m²;
  • Menopausal status;
  • Patient participating in another trial with an exclusion period that has not yet expired at the time of screening;
  • Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision;
  • Pregnant, breastfeeding, or postpartum woman.

Treatment and study plan

Pelvic Ultrasound

Procedure

Vaginal pelvic ultrasound. The examination is performed with an empty bladder using a 4-9 MHz vaginal probe positioned in a probe cover.

Anti-Müllerian hormone assay

Procedure

A minimum of 0.5 ml of blood is collected using a 0.8 mm diameter (21 G) hollow needle and collected in a dry SST tube with serum separation.

Questionnaire

Other

Visual Analogue Scale questionnaire Questionnaire EHP-5 (Endometriosis Health Profile) Questionnaire FSFI (Female Sexual Function Index)

Primary outcomes

  1. Percentage change in AMH (anti-mullerian hormone) levels between day 0 and month 12.

    Time frame: from enrollment to the end of the participation at 12 months

Study contacts

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

Jean-François Oudet

CONTACT

[email protected]

0033683346567

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Impact of Surgery for Deep Posterior Endometriosis on Ovarian Reserve

Acronym: ENDORO

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 13, 2026
Registry last updated
Jul 16, 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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