Clinical trial NCT02400684: ENDmetriosis and Reserve Ovarienne
Official title: ENDmetriosis and Reserve Ovarienne
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Endometriosis Stage III
Deep Endometriosis Stage IV
Keywords: AFSr classification
laparoscopy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in ovarian reserve (determined by AMH) at one year
timeFrame: Baseline : before surgery (less than one month) and one year after surgery
Secondary outcomes:
measure: Percentage of decline in AMH between patients who underwent ovarian cystectomy and those who did not
timeFrame: baseline and 1 year after surgery
measure: Evolution curve of AMH at 6 months and 1 year post-operatively
timeFrame: baseline, 6 months and 1 year after surgery
Other outcomes:
Locations:
city: Schiltigheim
country: France
facility: CMCO - Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Catherine RONGIERES, MD
role: PRINCIPAL_INVESTIGATOR
References: