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Completed

NCT Number: NCT02400684

ENDmetriosis and Reserve Ovarienne

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.

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Key information

Age range

18 year–37 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CMCO - Hôpitaux Universitaires de Strasbourg, Schiltigheim, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood samples

Biological

Evolution of AMH before and after deep endometriosis surgery

Primary outcomes

  1. Change from baseline in ovarian reserve (determined by AMH) at one year

    Time frame: Baseline : before surgery (less than one month) and one year after surgery

Secondary outcomes

  1. Percentage of decline in AMH between patients who underwent ovarian cystectomy and those who did not

    Time frame: baseline and 1 year after surgery

  2. Evolution curve of AMH at 6 months and 1 year post-operatively

    Time frame: baseline, 6 months and 1 year after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: ENDRO

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2015
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.