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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00713778
Other study ID # SPH-CL-030408
Secondary ID
Status Completed
Phase Phase 4
First received July 7, 2008
Last updated August 15, 2008
Start date November 2003
Est. completion date May 2008

Study information

Verified date July 2008
Source Shandong Provincial Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

Laparoscopic cystectomy is currently considered the treatment of choice in women with benign ovarian cysts and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad has recently been questioned. In the present study, with the combined use of serum hormonal evaluation and ultrasound examination, we planned to prospectively investigate the ovarian reserve after the excision of benign ovarian cysts. The damage to ovarian reserve will be evaluated through a 12-months follow-up after the application of bipolar, ultrasonic scalpel electrocoagulation or suture during ovarian cystectomy


Recruitment information / eligibility

Status Completed
Enrollment 192
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion criteria:

- 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

Exclusion criteria:

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Procedure:
Ovarian cystectomy
Laparoscopic ovarian cystectomy using bipolar
Ovarian cystectomy
Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation
Ovarian cystectomy
Laparotomic ovarian cystectomy using suture

Locations

Country Name City State
China Shandong Provincial Hospital Jinan Shandong

Sponsors (2)

Lead Sponsor Collaborator
Shandong Provincial Hospital Shandong University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Serum FSH and E2 assays 12 months Yes
Secondary Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity 12 months Yes
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