Deep Endometriosis Stage IIIENDRONCT02400684
ENDmetriosis and Reserve Ovarienne
An observational study of Deep Endometriosis Stage III and Deep Endometriosis Stage IV, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 37 years
- Conditions the study is for
- Deep Endometriosis Stage III, Deep Endometriosis Stage IV
- What is being tested?
- blood samples
- Type of treatment
- Injection or infusion
- How many people
- 118 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2015to Mar 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- All sexes
- No healthy volunteers
- Adult
Study population: Female between 18 and 38 years old Deep endometriosis stage III or IV endometriosis of AFSr classification who undergo laparoscopy
Who may be able to join
- 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
Who cannot join
- previous adnexectomy or adnexectomy during surgery
Trial locations and contacts
2 sites in 1 country.
France2 sites
CMCO - Hôpitaux Universitaires de Strasbourg
Schiltigheim, 67303
Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67200
About this study
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.
Read more
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.
- Being tested
- blood samples
- Keywords
- AFSr classification, laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
Evolution of AMH before and after deep endometriosis surgery
| Study group | Role | What they receive |
|---|---|---|
| Deep endometriosis | The population is a female population, above 18 years and under 38 years who have stage III or IV endometriosis (which will remain to be confirmed after inclusion by intra-operative observations), and who undergo operative laparoscopy in our center, with only deep endometriosis without endometriomas. Receives: Biological: blood samples | |
| Deep endometriosis and endométriomas | The population is a female population, above 18 years and under 38 years who have stage III or IV endometriosis (which will remain to be confirmed after inclusion by intra-operative observations), and who undergo operative laparoscopy in our center, with deep endometriosis and endometriomas. Receives: Biological: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in ovarian reserve (determined by AMH) at one year
Measured: Baseline : before surgery (less than one month) and one year after surgery
Secondary outcomes (2)
Percentage of decline in AMH between patients who underwent ovarian cystectomy and those who did not
Measured: baseline and 1 year after surgery
Evolution curve of AMH at 6 months and 1 year post-operatively
Measured: baseline, 6 months and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Endometriosis Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine RONGIERES, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400684
- Sponsor's protocol ID
- 6017
- Acronym
- ENDRO
- Status last verified
- Sep 2015
- First submitted
- 23 Mar 2015
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDmetriosis and Reserve Ovarienne
- ClinicalTrials.gov ID
- NCT02400684
- Acronym / sponsor ID
- ENDRO / 6017
- Keywords
- AFSr classification, laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep endometriosis | – | Biological: blood samplesThe population is a female population, above 18 years and under 38 years who have stage III or IV endometriosis (which will remain to be confirmed after inclusion by intra-operative observations), and who undergo operative laparoscopy in our center, with only deep endometriosis without endometriomas. |
| Deep endometriosis and endométriomas | – | Biological: blood samplesThe population is a female population, above 18 years and under 38 years who have stage III or IV endometriosis (which will remain to be confirmed after inclusion by intra-operative observations), and who undergo operative laparoscopy in our center, with deep endometriosis and endometriomas. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female between 18 and 38 years old Deep endometriosis stage III or IV endometriosis of AFSr classification who undergo laparoscopy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- previous adnexectomy or adnexectomy during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplesEvolution of AMH before and after deep endometriosis surgery | Biological | Deep endometriosis, Deep endometriosis and endométriomas |
Primary outcome
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
2 secondary outcomes
Percentage of decline in AMH between patients who underwent ovarian cystectomy and those who did not
Time frame: baseline and 1 year after surgery
Evolution curve of AMH at 6 months and 1 year post-operatively
Time frame: baseline, 6 months and 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine RONGIERES, MD principal investigator
Hôpitaux Universitaires de Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Endometriosis Stage III and Deep Endometriosis Stage IV, run by University Hospital, Strasbourg, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.