ENDmetriosis and Reserve Ovarienne (ENDRO)

Endometriosis is the ectopic implantation of endometrial glands and stroma, and can be ovarian and peritoneal (superficial or deep). There are 4 stages in endometriosis according to severity, and the stage is established on the basis of intra-operative observations. The AFSr classification is currently most used (I-IV,minimal, mild, moderate, severe). Most associated with endometriosis are subfertility and pelvic pain.

In the surgical management of deep endometriosis, the issue of fertility is pivotal. There is a higher rate of infertility in a population of women with endometriosis as compared to the general population, even though the mechanisms are not yet elucidated. Patients with deep endometriosis can be referred to the surgeon for subfertility, but even when they are referred for chronic pain, future fertility considerations are taken into account in the planning of the surgery, as the patients are often young.

It is now well documented that ovarian cystectomy is deleterious with regards to the ovarian reserve, and more so in endometriomas than in any other type of benign cysts. The ovarian reserve is the functional potential of the ovaries, reflecting the quantity and quality of remaining follicles. Studies have also relied greatly on the measure of serum anti-mullerian hormone (AMH) to evaluate the effect of cystectomy on ovarian reserve, as AMH is currently the most reliable marker to assess ovarian reserve. A significant difference was found between AMH before and following cystectomy in several studies. The deleterious effect of deep endometriosis surgery which comprises a wide dissection and adhesiolysis of the pelvis in many cases, even when no cystectomy has been performed, is therefore not entirely ruled out. To the best of our knowledge, there are no studies on the effect of deep endometriosis surgery, apart from ovarian surgery, on ovarian reserve.

Our center is very active in the laparoscopic surgical treatment of deep endometriosis, with more than 200 cases every year. The objective of this trial is to assess the effect of deep endometriosis surgery on the ovarian reserve, whether a cystectomy is performed or not, by measuring serum AMH before and after surgery, at 6 months and 1 year post-operatively.

Study Overview

• Status: Completed
• Conditions: Deep Endometriosis Stage III; Deep Endometriosis Stage IV
• Intervention / Treatment: Biological: blood samples

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• France
  • Schiltigheim, France, 67303
    • CMCO - Hôpitaux Universitaires de Strasbourg
  • Strasbourg, France, 67200
    • Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Female between 18 and 38 years old Deep endometriosis stage III or IV endometriosis of AFSr classification who undergo laparoscopy

Description

Inclusion Criteria:

• female patient between 18 and 38 years
• endometriosis stage III or IV in the AFSr classification
• laparoscopy included deep endometriosis procedures (adhesiolysis, ureterolysis, cystectomy, resection of bowel, urinary or deep peritoneal endometriosis)
• written informed consent

Exclusion Criteria:

• previous adnexectomy or adnexectomy during surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Deep endometriosis; The population is a female population, above 18 years and under 38 years who have stage III or IV endometriosis (which will remain to be confirmed after inclusion by intra-operative observations), and who undergo operative laparoscopy in our center, with only deep endometriosis without endometriomas.	Biological: blood samples; Evolution of AMH before and after deep endometriosis surgery
Deep endometriosis and endométriomas; The population is a female population, above 18 years and under 38 years who have stage III or IV endometriosis (which will remain to be confirmed after inclusion by intra-operative observations), and who undergo operative laparoscopy in our center, with deep endometriosis and endometriomas.	Biological: blood samples; Evolution of AMH before and after deep endometriosis surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in ovarian reserve (determined by AMH) at one year	Baseline : before surgery (less than one month) and one year after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of decline in AMH between patients who underwent ovarian cystectomy and those who did not	baseline and 1 year after surgery
Evolution curve of AMH at 6 months and 1 year post-operatively	baseline, 6 months and 1 year after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Catherine RONGIERES, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: laparoscopy; AFSr classification
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 6017