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A Random Clinical Trial of the Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst


Phase 4
18 Years
40 Years
Not Enrolling
Female
Ovarian Cyst

Thank you

Trial Information

A Random Clinical Trial of the Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst


Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women
with benign ovarian cyst and has gained increasing acceptance among gynecological
surgeons(1). However, the safety of this technique in terms of ovarian damage to the
operated gonad caused by electrocoagulation has recently been questioned. Many evidences
support that the removal of ovarian cysts is associated with an injury to ovarian reserve.
On the contrary, some retrospective studies did not show adverse outcomes compared with the
control group (tubal infertility) . There is a lack of good clinical and scientific evidence
such as randomized controlled study to report definitively the impact of electrocoagulation
on ovarian reserve after laparoscopic excision of ovarian cyst.


Inclusion Criteria:



- age 18-40 years

- ultrasound diagnosis as unilateral ovarian cyst and the average size between 5cm and
10cm

- no clinical and sonographic suspicion of ovarian cancer

- regular menstrual cycles defined as cycle length between 25 and 35 days in the 6
months before surgery

- sonographic normal contralateral ovary

- agreement to be enrolled in the study.

Exclusion Criteria:

- prior ovarian surgery or known endocrine disease

- surgical necessity to perform adnexectomy

- intraoperative diagnosis of an abnormal contralateral ovary

- post operative pathologic diagnosis was not benign ovarian cyst

- oral contraceptive use before surgery.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Chang-Zhong Li,, M.D.Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Shandong Provincial Hospital

Authority:

China: Ministry of Health

Study ID:

SPH-CL-080512

NCT ID:

NCT00746278

Start Date:

September 2008

Completion Date:

February 2010

Related Keywords:

  • Ovarian Cyst
  • Ovarian Cysts
  • Electrocoagulation
  • Ovarian Function Tests
  • Laparoscopy
  • Cysts
  • Ovarian Cysts

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