Deep Endometriosis Stage III Clinical Trial
— ENDROOfficial title:
ENDmetriosis and Reserve Ovarienne
| NCT number | NCT02400684 |
| Other study ID # | 6017 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2015 |
| Est. completion date | March 2019 |
| Verified date | September 2015 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 118 |
| Est. completion date | March 2019 |
| Est. primary completion date | March 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 37 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CMCO - Hôpitaux Universitaires de Strasbourg | Schiltigheim | |
| France | Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Percentage of decline in AMH between patients who underwent ovarian cystectomy and those who did not | baseline and 1 year after surgery | ||
| Secondary | Evolution curve of AMH at 6 months and 1 year post-operatively | baseline, 6 months and 1 year after surgery |