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The Impact on Ovarian Reserve After Ovarian Hemostasis by Floseal Hemostatic Matrix Versus Bipolar Coagulation: a Randomized Controlled Trial


Phase 3
18 Years
45 Years
Open (Enrolling)
Female
Ovarian Cysts

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Trial Information

The Impact on Ovarian Reserve After Ovarian Hemostasis by Floseal Hemostatic Matrix Versus Bipolar Coagulation: a Randomized Controlled Trial


Inclusion Criteria:



- largest diameter of the ovarian cyst between 3 and 15 cm

- regular menstrual bleeding

- appropriate medical status for laparoscopic surgery (American Society of
Anesthesiologists Physical Status classification 1 or 2).

Exclusion Criteria:

- the evidence of polycystic ovarian syndrome (according to the Rotterdam criteria)

- pregnancy, lactation, any other endocrine diseases

- use of hormonal treatments in the 3 months before enrollment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Serum AMH levels

Outcome Description:

The primary outcome of the study was the impact on ovarian reserve determined by serum AMH levels after the applications of two hemostatic techniques for ovarian wound bleeding.

Outcome Time Frame:

3 months after therapy

Safety Issue:

No

Principal Investigator

Taejong Song, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHA Gangnam Medical Center, Seoul, Republic of Korea

Authority:

Republic of Korea: Institutional Review Board

Study ID:

KNC13-017

NCT ID:

NCT01857466

Start Date:

May 2013

Completion Date:

May 2014

Related Keywords:

  • Ovarian Cysts
  • Ovarian Cysts

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