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| Tracking Information | |||||
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| First Received Date ICMJE | July 7, 2008 | ||||
| Last Updated Date | August 15, 2008 | ||||
| Start Date ICMJE | November 2003 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Serum FSH and E2 assays [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
serum FSH and E2 assays [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00713778 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst | ||||
| Official Title ICMJE | The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc | ||||
| 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. |
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| Detailed 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 |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Supportive Care, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Ovarian Cysts | ||||
| Intervention ICMJE | Procedure: Ovarian cystectomy | ||||
| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 192 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00713778 | ||||
| Responsible Party | Xiayong Wang Ph.D, Shandong Provincial Hospital | ||||
| Study ID Numbers ICMJE | SPH-CL-030408 | ||||
| Study Sponsor ICMJE | Shandong Provincial Hospital | ||||
| Collaborators ICMJE | Shandong University | ||||
| Investigators ICMJE |
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| Information Provided By | Shandong Provincial Hospital | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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