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

June 25, 2013 updated by: Leonidas Magarakis, Karlstad Central Hospital
Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation has an effect on ovarian reserve.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Värmaland
      • Karlstad, Värmaland, Sweden, 65185
        • Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tubal Sterilization with bipolar
Salpingectomy vs Tubal Sterilisation
Procedure: Tubal sterilization with bipolar energy
ACTIVE_COMPARATOR: Bilateral Salpingectomy
Salpingectomy vs Tubal Sterilisation
Procedure: Bilateral Salpingectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Anti-Mullerian hormone (AMH)
Time Frame: 1 year
1 year
Operative time
Time Frame: Postoperatively
Postoperatively
Complications
Time Frame: 3 months
3 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karlstad Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ANTICIPATED)

September 1, 2014

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (ESTIMATE)

June 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEvsTSinAMH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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