Salpingectomy vs Tubal Sterilisation in Low Risk for Ovar... | NCT01888159

Studies
Salpingectomy vs Tubal Sterilisation in Low Risk for Ovarian Cancer Women and Its Effect on Ovarian Reserve

NCT01888159

Sponsor

Karlstad Central Hospital

Status

Unknown status

Last Update Posted

Jun 27, 2013Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Ovarian Cancer

Interventions

Bilateral Salpingectomy
Tubal sterilization with bipolar energy

Countries

Sweden

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 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Sep 2014Estimated

Completion Date

Not provided

First Submitted Date

Jun 20, 2013

First Submission Date that Met QC Criteria

Jun 25, 2013

First Posted Date

Jun 27, 2013Estimated

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

Jun 25, 2013

Last Update Posted Date

Jun 27, 2013Estimated

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

Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation has an effect on ovarian reserve.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tubal Sterilization with bipolar	Active Comparator	Salpingectomy vs Tubal Sterilisation	Procedure: Tubal sterilization with bipolar energy
Bilateral Salpingectomy	Active Comparator	Salpingectomy vs Tubal Sterilisation	Procedure: Bilateral Salpingectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bilateral Salpingectomy	Procedure		Bilateral Salpingectomy
Tubal sterilization with bipolar energy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-Mullerian hormone (AMH)and Follicle Stimulation Hormone (FSH)		3 months

Secondary Outcomes

Measure	Description	Time Frame
Anti-Mullerian hormone (AMH)		1 year
Operative time		Postoperatively
Complications

Other Outcomes

Measure	Description	Time Frame
Follicle Stimulation Hormone (FSH)		3 months
Follicle Stimulation Hormone (FSH)		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women seeking for tubal sterilisation

Exclusion Criteria:

women older than 45
family history of ovarian cancer
presence of menopausal symptoms
irregular cycles
Hormone Replacement Therapy or hormone contraceptions the last 3 months
history of previous ovarian or uterine surgeries
imaging suggesting an ovarian cyst or other adnexal pathology during investigation
previous salpingectomy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leonidas Magarakis, MD	Contact	046737529929		lemagarakis@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology		Karlstad	Värmaland	65185	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013246	Sterilization, Tubal

Ancestor Terms

ID	Term
D013509	Gynecologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative
D013245	Sterilization, Reproductive

Browse Leaves

Not provided

Browse Branches

Not provided