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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. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Leonidas Magarakis, 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Leonidas Magarakis, Karlstad Central Hospital:

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

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

Other Outcome Measures:
  • Follicle Stimulation Hormone (FSH) [ Time Frame: 3 months ]
  • Follicle Stimulation Hormone (FSH) [ Time Frame: 1 year ]

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   (Adult)
Sexes 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
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 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

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Anti-Infective Agents processed this record on September 19, 2017