Laparoscopic Surgical Management of Endometriosis on Fert... | NCT02481739

Studies
Laparoscopic Surgical Management of Endometriosis on Fertility

NCT02481739

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jan 6, 2017Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Endometriosis

Interventions

retrospective study

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Jun 7, 2015

First Submission Date that Met QC Criteria

Jun 24, 2015

First Posted Date

Jun 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2017

Last Update Posted Date

Jan 6, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
retrospective study	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
benefit of endometriosis surgery on fertility : occurrence of pregnancy or live birth, spontaneous or after use of a MPA technical		after surgery, up to 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients over 18 years
Patients operated by laparoscopy for endometriosis in our department between 2006 and 2014.

Exclusion Criteria:

Patients under 18 years

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

This work concerns patients aged 18-38 years, operated by laparoscopy for endometriosis in our department between 2006 and 2014

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arnaud WATTIEZ, MD	Contact	03.88.12.74.83		arnaud.wattiez@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Arnaud WATTIEZ, MD	University Hospital, Strasbourg, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Gynécologie	Recruiting	Strasbourg	France	67091	France

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012189	Retrospective Studies

Ancestor Terms

ID	Term
D016022	Case-Control Studies
D016021	Epidemiologic Studies
D016020	Epidemiologic Study Characteristics
D004812	Epidemiologic Methods

Browse Leaves

Not provided

Browse Branches

Not provided