NCT00746278

Brief Summary

Laparoscopic ovarian cystectomy is widely used for the removal of benign ovarian cysts but damage to ovarian reserve caused by electrocoagulation has recently been questioned. The purpose of this study is to investigate the impact of bipolar and ultrasonic scalpel electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 26, 2010

Status Verified

May 1, 2008

Enrollment Period

1 year

First QC Date

August 29, 2008

Last Update Submit

February 25, 2010

Conditions

Ovarian Cyst

Keywords

Ovarian CystsElectrocoagulationOvarian Function TestsLaparoscopy

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (1)

  • Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity

    12 months

Study Arms (3)

1

EXPERIMENTAL

Laparoscopic ovarian cystectomy using bipolar

Procedure: Laparoscopic ovarian cystectomy using bipolar

2

EXPERIMENTAL

Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation

Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpel

3

ACTIVE COMPARATOR

Laparoscopic ovarian cystectomy using suture

Procedure: Laparoscopic ovarian cystectomy using suture

Interventions

Laparoscopic ovarian cystectomy using bipolarPROCEDURE

Laparoscopic ovarian cystectomy using bipolar

1
Laparoscopic ovarian cystectomy using ultrasonic scalpelPROCEDURE

Laparoscopic ovarian cystectomy using ultrasonic scalpel

2
Laparoscopic ovarian cystectomy using suturePROCEDURE

Laparoscopic ovarian cystectomy using suture

3

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

Related Publications (5)

  • Candiani M, Barbieri M, Bottani B, Bertulessi C, Vignali M, Agnoli B, Somigliana E, Busacca M. Ovarian recovery after laparoscopic enucleation of ovarian cysts: insights from echographic short-term postsurgical follow-up. J Minim Invasive Gynecol. 2005 Sep-Oct;12(5):409-14. doi: 10.1016/j.jmig.2005.06.006.

    PMID: 16213426BACKGROUND

  • Ho HY, Lee RK, Hwu YM, Lin MH, Su JT, Tsai YC. Poor response of ovaries with endometrioma previously treated with cystectomy to controlled ovarian hyperstimulation. J Assist Reprod Genet. 2002 Nov;19(11):507-11. doi: 10.1023/a:1020970417778.

    PMID: 12484492BACKGROUND

  • Loh FH, Tan AT, Kumar J, Ng SC. Ovarian response after laparoscopic ovarian cystectomy for endometriotic cysts in 132 monitored cycles. Fertil Steril. 1999 Aug;72(2):316-21. doi: 10.1016/s0015-0282(99)00207-1.

    PMID: 10439003BACKGROUND

  • Nargund G, Cheng WC, Parsons J. The impact of ovarian cystectomy on ovarian response to stimulation during in-vitro fertilization cycles. Hum Reprod. 1996 Jan;11(1):81-3. doi: 10.1093/oxfordjournals.humrep.a019043.

    PMID: 8671163BACKGROUND

  • Somigliana E, Ragni G, Benedetti F, Borroni R, Vegetti W, Crosignani PG. Does laparoscopic excision of endometriotic ovarian cysts significantly affect ovarian reserve? Insights from IVF cycles. Hum Reprod. 2003 Nov;18(11):2450-3. doi: 10.1093/humrep/deg432.

    PMID: 14585900BACKGROUND

MeSH Terms

Conditions

Ovarian CystsHyperthermia

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Officials

  • Chang-Zhong Li,, M.D.Ph.D.

    Shandong Provincial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 3, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

February 1, 2010

Last Updated

February 26, 2010

Record last verified: 2008-05

Locations

CN(1)