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

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ClinicalTrials.gov Identifier: NCT01888159
Recruitment Status : Unknown
Verified June 2013 by Leonidas Magarakis, Karlstad Central Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation has an effect on ovarian reserve.

Condition or disease Intervention/treatment
Ovarian Cancer Procedure: Bilateral Salpingectomy Procedure: Tubal sterilization with bipolar energy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : September 2013
Estimated Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Leonidas Magarakis, MD, Karlstad Central Hospital
ClinicalTrials.gov Identifier: NCT01888159     History of Changes
Other Study ID Numbers: SEvsTSinAMH
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013

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