Ovarian CystPhase 4NCT00746278
A Random Clinical Trial (RCT) of the Impact of Electrocoagulation on Ovarian Reserve
A Phase 4 study testing Laparoscopic ovarian cystectomy using bipolar, Laparoscopic ovarian cystectomy using ultrasonic scalpel and Laparoscopic ovarian cystectomy using suture in people with Ovarian Cyst, run by Shandong Provincial Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Cyst
- What is being tested?
- Laparoscopic ovarian cystectomy using bipolar, Laparoscopic ovarian cystectomy using ultrasonic scalpel and Laparoscopic ovarian cystectomy using suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Feb 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Random Clinical Trial of the Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst
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.
Read the detailed description
Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with benign ovarian cyst and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad caused by electrocoagulation has recently been questioned. Many evidences support that the removal of ovarian cysts is associated with an injury to ovarian reserve. On the contrary, some retrospective studies did not show adverse outcomes compared with the control group (tubal infertility) . There is a lack of good clinical and scientific evidence such as randomized controlled study to report definitively the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.
- Conditions
- Ovarian Cyst
- Being tested
- Laparoscopic ovarian cystectomy using bipolar, Laparoscopic ovarian cystectomy using ultrasonic scalpel, Laparoscopic ovarian cystectomy using suture
- Keywords
- Ovarian Cysts, Electrocoagulation, Ovarian Function Tests, Laparoscopy
- Medical subject headings
- Ovarian Cysts, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ovarian cystectomy using bipolarProcedure or surgery
Laparoscopic ovarian cystectomy using bipolar
Laparoscopic ovarian cystectomy using ultrasonic scalpelProcedure or surgery
Laparoscopic ovarian cystectomy using ultrasonic scalpel
Laparoscopic ovarian cystectomy using sutureProcedure or surgery
Laparoscopic ovarian cystectomy using suture
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Laparoscopic ovarian cystectomy using bipolar Receives: Procedure: Laparoscopic ovarian cystectomy using bipolar |
| 2 | Experimental | Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation Receives: Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpel |
| 3 | Active comparator | Laparoscopic ovarian cystectomy using suture Receives: Procedure: Laparoscopic ovarian cystectomy using suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays
Measured: 12 months
Secondary outcomes (1)
Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ovarian CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Shandong University
- Investigators
- Chang-Zhong Li,, M.D.Ph.D., Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746278
- Sponsor's protocol ID
- SPH-CL-080512
- Status last verified
- May 2008
- First submitted
- 29 Aug 2008
- Last updated
- 26 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16213426Ho 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.
PubMed 12484492Loh 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.
PubMed 10439003Nargund 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.
PubMed 8671163Somigliana 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.
PubMed 14585900
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Random Clinical Trial of the Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst
- ClinicalTrials.gov ID
- NCT00746278
- Acronym / sponsor ID
- SPH-CL-080512
- Conditions
- Ovarian Cyst
- Keywords
- Ovarian Cysts, Electrocoagulation, Ovarian Function Tests, Laparoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Collaborators
- Shandong University
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with benign ovarian cyst and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad caused by electrocoagulation has recently been questioned. Many evidences support that the removal of ovarian cysts is associated with an injury to ovarian reserve. On the contrary, some retrospective studies did not show adverse outcomes compared with the control group (tubal infertility) . There is a lack of good clinical and scientific evidence such as randomized controlled study to report definitively the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Laparoscopic ovarian cystectomy using bipolarLaparoscopic ovarian cystectomy using bipolar |
| 2 | Experimental | Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpelLaparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation |
| 3 | Active comparator | Procedure: Laparoscopic ovarian cystectomy using sutureLaparoscopic ovarian cystectomy using suture |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic ovarian cystectomy using bipolarLaparoscopic ovarian cystectomy using bipolar | Procedure or surgery | 1 |
| Laparoscopic ovarian cystectomy using ultrasonic scalpelLaparoscopic ovarian cystectomy using ultrasonic scalpel | Procedure or surgery | 2 |
| Laparoscopic ovarian cystectomy using sutureLaparoscopic ovarian cystectomy using suture | Procedure or surgery | 3 |
Primary outcome
Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays
Time frame: 12 months
1 secondary outcome
Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
- Background: PubMed 16213426Candiani 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.
- Background: PubMed 12484492Ho 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.
- Background: PubMed 10439003Loh 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.
- Background: PubMed 8671163Nargund 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.
- Background: PubMed 14585900Somigliana 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Zhong Li,, M.D.Ph.D. study chair
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic ovarian cystectomy using bipolar, Laparoscopic ovarian cystectomy using ultrasonic scalpel and Laparoscopic ovarian cystectomy using suture in people with Ovarian Cyst, run by Shandong Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00746278, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.