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NCT01888159 Clinical Trial

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

Ovarian Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01888159
Other study ID # SEvsTSinAMH
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 20, 2013
Last updated June 25, 2013
Start date September 2013

Study information
Verified date June 2013
Source Karlstad Central Hospital
Contact Leonidas Magarakis, MD
Phone 046737529929
Email lemagarakis@gmail.com
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 45 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• Bilateral Salpingectomy

• Tubal sterilization with bipolar energy

Locations
Country Name City State
Sweden Department of Obstetrics and Gynecology Karlstad Värmaland

Sponsors (1)
Lead Sponsor Collaborator
Karlstad Central Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Other Follicle Stimulation Hormone (FSH) 3 months Yes
Other Follicle Stimulation Hormone (FSH) 1 year Yes
Primary Anti-Mullerian hormone (AMH)and Follicle Stimulation Hormone (FSH) 3 months Yes
Secondary Anti-Mullerian hormone (AMH) 1 year Yes
Secondary Operative time Postoperatively Yes
Secondary Complications 3 months Yes
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