EndometriosisNCT02481739
Laparoscopic Surgical Management of Endometriosis on Fertility
An observational study of Endometriosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The aim of the investigators study is to know the results of the endometriosis surgery and particularly to highlight a benefit of this surgery on fertility. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- retrospective study
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Sep 2017
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: This work concerns patients aged 18-38 years, operated by laparoscopy for endometriosis in our department between 2006 and 2014
Who may be able to join
- Patients over 18 years
- Patients operated by laparoscopy for endometriosis in our department between 2006 and 2014.
Who cannot join
- Patients under 18 years
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Gynécologie
Strasbourg, France, 67091
Arnaud Wattiez, MD, 03.88.12.74.83, arnaud.wattiez@chru-strasbourg.fr
About this study
Official title: Study of the Impact of Laparoscopic Surgical Management of Endometriosis on Fertility
The aim of the investigators study is to know the results of the endometriosis surgery and particularly to highlight a benefit of this surgery on fertility.
- Conditions
- Endometriosis
- Being tested
- retrospective study
- Keywords
- endometriosis, fertility, endometriosis surgery
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
benefit of endometriosis surgery on fertility : occurrence of pregnancy or live birth, spontaneous or after use of a MPA technical
Measured: after surgery, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud WATTIEZ, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481739
- Sponsor's protocol ID
- 6201
- Status last verified
- Jun 2015
- First submitted
- 7 Jun 2015
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Laparoscopic Surgical Management of Endometriosis on Fertility
- ClinicalTrials.gov ID
- NCT02481739
- Acronym / sponsor ID
- 6201
- Conditions
- Endometriosis
- Keywords
- endometriosis, fertility, endometriosis surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 25 Jun 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.
The aim of the investigators study is to know the results of the endometriosis surgery and particularly to highlight a benefit of this surgery on fertility.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This work concerns patients aged 18-38 years, operated by laparoscopy for endometriosis in our department between 2006 and 2014
Key inclusion criteria (2 listed)
- Patients over 18 years
- Patients operated by laparoscopy for endometriosis in our department between 2006 and 2014.
Key exclusion criteria (1 listed)
- Patients under 18 years
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 |
|---|---|---|
| retrospective study | Other | – |
Primary outcome
benefit of endometriosis surgery on fertility : occurrence of pregnancy or live birth, spontaneous or after use of a MPA technical
Time frame: after surgery, up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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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.
Arnaud WATTIEZ, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University Hospital, Strasbourg, France at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud WATTIEZ, MD (03.88.12.74.83, arnaud.wattiez@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
benefit of endometriosis surgery on fertility : occurrence of pregnancy or live birth, spontaneous or after use of a MPA technical (time frame: after surgery, up to 1 year). 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 6 Jan 2017.