NCT01888159

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

June 20, 2013

Last Update Submit

June 25, 2013

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (3)

  • Anti-Mullerian hormone (AMH)

    1 year

  • Operative time

    Postoperatively

  • Complications

    3 months

Other Outcomes (2)

  • Follicle Stimulation Hormone (FSH)

    3 months

  • Follicle Stimulation Hormone (FSH)

    1 year

Study Arms (2)

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

Bilateral SalpingectomyPROCEDURE
Bilateral Salpingectomy
Tubal sterilization with bipolar energyPROCEDURE
Tubal Sterilization with bipolar

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women seeking for tubal sterilisation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology

Karlstad, Värmaland, 65185, Sweden

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Sterilization, Tubal

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, OperativeSterilization, Reproductive

Central Study Contacts

Leonidas Magarakis, MD

CONTACT

046737529929lemagarakis@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 27, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Last Updated

June 27, 2013

Record last verified: 2013-06

Locations

SE(1)