Ovarian Cyst Clinical Trial
Official title:
A Random Clinical Trial of the Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst
Verified date | May 2008 |
Source | Shandong Provincial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | February 2010 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Shandong Provincial Hospital | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong Provincial Hospital | Shandong University |
China,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) 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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