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

NCT ID: NCT01888159

Last Updated: 2013-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Brief Summary

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

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Bilateral Salpingectomy

Salpingectomy vs Tubal Sterilisation

Group Type ACTIVE_COMPARATOR

Bilateral Salpingectomy

Intervention Type PROCEDURE

Tubal Sterilization with bipolar

Salpingectomy vs Tubal Sterilisation

Group Type ACTIVE_COMPARATOR

Tubal sterilization with bipolar energy

Intervention Type PROCEDURE

Interventions

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Bilateral Salpingectomy

Intervention Type PROCEDURE

Tubal sterilization with bipolar energy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karlstad Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Leonidas Magarakis

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Obstetrics and Gynecology

Karlstad, Värmaland, Sweden

Site Status

Countries

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Sweden

Central Contacts

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Leonidas Magarakis, MD

Role: CONTACT

046737529929

Other Identifiers

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SEvsTSinAMH

Identifier Type: -

Identifier Source: org_study_id

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