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ENDmetriosis and Reserve Ovarienne

ENDmetriosis and Reserve Ovarienne

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02400684
Acronym
ENDRO
Enrollment
118
Registered
2015-03-27
Start date
2015-06-30
Completion date
2019-03-31
Last updated
2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Endometriosis Stage III, Deep Endometriosis Stage IV

Keywords

AFSr classification, 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.

Interventions

BIOLOGICALblood samples

Evolution of AMH before and after deep endometriosis surgery

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 37 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in ovarian reserve (determined by AMH) at one yearBaseline : before surgery (less than one month) and one year after surgery

Secondary

MeasureTime frame
Percentage of decline in AMH between patients who underwent ovarian cystectomy and those who did notbaseline and 1 year after surgery
Evolution curve of AMH at 6 months and 1 year post-operativelybaseline, 6 months and 1 year after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026