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

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bilateral Salpingectomy
Tubal sterilization with bipolar energy
Sponsored by
Karlstad Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Cancer

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tubal Sterilization with bipolar

Bilateral Salpingectomy

Arm Description

Salpingectomy vs Tubal Sterilisation

Salpingectomy vs Tubal Sterilisation

Outcomes

Primary Outcome Measures

Anti-Mullerian hormone (AMH)and Follicle Stimulation Hormone (FSH)

Secondary Outcome Measures

Anti-Mullerian hormone (AMH)
Operative time
Complications

Full Information

First Posted
June 20, 2013
Last Updated
June 25, 2013
Sponsor
Karlstad Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01888159
Brief Title
Salpingectomy vs Tubal Sterilisation in Low Risk for Ovarian Cancer Women and Its Effect on Ovarian Reserve
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karlstad Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tubal Sterilization with bipolar
Arm Type
Active Comparator
Arm Description
Salpingectomy vs Tubal Sterilisation
Arm Title
Bilateral Salpingectomy
Arm Type
Active Comparator
Arm Description
Salpingectomy vs Tubal Sterilisation
Intervention Type
Procedure
Intervention Name(s)
Bilateral Salpingectomy
Intervention Type
Procedure
Intervention Name(s)
Tubal sterilization with bipolar energy
Primary Outcome Measure Information:
Title
Anti-Mullerian hormone (AMH)and Follicle Stimulation Hormone (FSH)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Anti-Mullerian hormone (AMH)
Time Frame
1 year
Title
Operative time
Time Frame
Postoperatively
Title
Complications
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Follicle Stimulation Hormone (FSH)
Time Frame
3 months
Title
Follicle Stimulation Hormone (FSH)
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonidas Magarakis, MD
Phone
046737529929
Email
lemagarakis@gmail.com
Facility Information:
Facility Name
Department of Obstetrics and Gynecology
City
Karlstad
State/Province
Värmaland
ZIP/Postal Code
65185
Country
Sweden

12. IPD Sharing Statement

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

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