NCT00713778

Brief Summary

The purpose of this study is to investigate the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst and the possible mechanisms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_4

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

Study Start

First participant enrolled

November 1, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
Last Updated

August 18, 2008

Status Verified

July 1, 2008

Enrollment Period

4.5 years

First QC Date

July 7, 2008

Last Update Submit

August 15, 2008

Conditions

Ovarian Cysts

Keywords

Ovarian CystsElectrocoagulationOvarian Function TestsLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Serum FSH and E2 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: Ovarian cystectomy

2

EXPERIMENTAL

Laparoscopic ovarian cystectomy using ultrasonic scalpel

Procedure: Ovarian cystectomy

3

ACTIVE COMPARATOR

Laparotomic ovarian cystectomy using suture

Procedure: Ovarian cystectomy

Interventions

Ovarian cystectomyPROCEDURE

Laparoscopic ovarian cystectomy using bipolar

Also known as: laparoscopic ovarian cystectomy using bipolar
1

Eligibility Criteria

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

You may qualify if:

  • Age 18-40 years
  • Uni/bilateral ovarian cyst(s) without 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
  • Agreement to be enrolled in the study

You may not qualify if:

  • Prior ovarian surgery
  • Surgical necessity to perform adnexectomy
  • Known endocrine disease
  • 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

  • changzhong li, M.D.

    Shandong Provincial Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 11, 2008

Study Start

November 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 18, 2008

Record last verified: 2008-07

Locations

CN(1)