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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Karlstad Central Hospital
Sponsor:
Information provided by (Responsible Party):
Leonidas Magarakis, Karlstad Central Hospital
ClinicalTrials.gov Identifier:
NCT01888159
First received: June 20, 2013
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Ovarian Cancer
Procedure: Bilateral Salpingectomy
Procedure: Tubal sterilization with bipolar energy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Karlstad Central Hospital:

Primary Outcome Measures:
  • Anti-Mullerian hormone (AMH)and Follicle Stimulation Hormone (FSH) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anti-Mullerian hormone (AMH) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Operative time [ Time Frame: Postoperatively ] [ Designated as safety issue: Yes ]
  • Complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Follicle Stimulation Hormone (FSH) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Follicle Stimulation Hormone (FSH) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01888159

Contacts
Contact: Leonidas Magarakis, MD 046737529929 lemagarakis@gmail.com

Locations
Sweden
Department of Obstetrics and Gynecology Not yet recruiting
Karlstad, Värmaland, Sweden, 65185
Sponsors and Collaborators
Karlstad Central Hospital
  More Information

No publications provided

Responsible Party: Leonidas Magarakis, MD, Karlstad Central Hospital
ClinicalTrials.gov Identifier: NCT01888159     History of Changes
Other Study ID Numbers: SEvsTSinAMH
Study First Received: June 20, 2013
Last Updated: June 25, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014