Ignite Creation Date:
2024-05-06 @ 3:55 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02400684
Status:
COMPLETED
Last Update Posted:
2020-05-29
First Post:
2015-03-23
Brief Title:
ENDmetriosis and Reserve Ovarienne
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
ENDmetriosis and Reserve Ovarienne
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDRO
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-IVminimal 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None