ENDmetriosis and Reserve Ovarienne

NCT02400684 | Completed

• 1 other identifier: 6017
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Deep Endometriosis Stage III; Deep Endometriosis Stage IV

Keywords

AFSr classification; laparoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

blood samples BIOLOGICAL

Evolution of AMH before and after deep endometriosis surgery

Deep endometriosis; Deep endometriosis and endométriomas

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• previous adnexectomy or adnexectomy during surgery

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (2)

CMCO - Hôpitaux Universitaires de Strasbourg

Schiltigheim, 67303, France

Location

Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67200, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

3 times blood sample retrieval and use serum to measure AMH the primary end point but also FSH, LH, estradiol which are study usually.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Catherine RONGIERES, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 27, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 29, 2020

Record last verified: 2015-09

Locations

FR (2)