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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2013 by Karlstad Central Hospital.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Leonidas Magarakis, Karlstad Central Hospital Identifier:
First received: June 20, 2013
Last updated: June 25, 2013
Last verified: June 2013
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


Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01888159

Contact: Leonidas Magarakis, MD 046737529929

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 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
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 11, 2016