Ovarian CystsPhase 4NCT00713778
The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst
A Phase 4 study testing Ovarian cystectomy in people with Ovarian Cysts, run by Shandong Provincial Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Cysts
- What is being tested?
- Ovarian cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- Nov 2003to May 2008
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc
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.
Read the 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
- Conditions
- Ovarian Cysts
- Being tested
- Ovarian cystectomy
- 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.
Ovarian cystectomyProcedure or surgery
Also called laparoscopic ovarian cystectomy using bipolar
Laparoscopic ovarian cystectomy using bipolar
Ovarian cystectomyProcedure or surgery
Also called laparoscopic ovarian cystectomy using ultrasonic scalpel
Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation
Ovarian cystectomyProcedure or surgery
Also called Laparotomic ovarian cystectomy using suture
Laparotomic ovarian cystectomy using suture
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Laparoscopic ovarian cystectomy using bipolar Receives: Procedure: Ovarian cystectomy |
| 2 | Experimental | Laparoscopic ovarian cystectomy using ultrasonic scalpel Receives: Procedure: Ovarian cystectomy |
| 3 | Active comparator | Laparotomic ovarian cystectomy using suture Receives: Procedure: Ovarian cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum FSH and E2 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 posted11 Jul 2008 (estimated)
- Study startNov 2003
- Primary completionMay 2008
- Study completionMay 2008
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 CystsStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Shandong University
- Investigators
- changzhong li, M.D., Study director, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713778
- Sponsor's protocol ID
- SPH-CL-030408
- Status last verified
- Jul 2008
- First submitted
- 7 Jul 2008
- Last updated
- 18 Aug 2008
- 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 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc
- ClinicalTrials.gov ID
- NCT00713778
- Acronym / sponsor ID
- SPH-CL-030408
- Conditions
- Ovarian Cysts
- Keywords
- Ovarian Cysts, Electrocoagulation, Ovarian Function Tests, Laparoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Collaborators
- Shandong University
- Study start
- Nov 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 11 Jul 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.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Ovarian cystectomyLaparoscopic ovarian cystectomy using bipolar |
| 2 | Experimental | Procedure: Ovarian cystectomyLaparoscopic ovarian cystectomy using ultrasonic scalpel |
| 3 | Active comparator | Procedure: Ovarian cystectomyLaparotomic 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 (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Ovarian cystectomyAlso: laparoscopic ovarian cystectomy using bipolarLaparoscopic ovarian cystectomy using bipolar | Procedure or surgery | 1 |
| Ovarian cystectomyAlso: laparoscopic ovarian cystectomy using ultrasonic scalpelLaparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation | Procedure or surgery | 2 |
| Ovarian cystectomyAlso: Laparotomic ovarian cystectomy using sutureLaparotomic ovarian cystectomy using suture | Procedure or surgery | 3 |
Primary outcome
Serum FSH and E2 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 18 Aug 2008.
- 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.
changzhong li, M.D. study director
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 Ovarian cystectomy in people with Ovarian Cysts, 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 4 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 18 Aug 2008. 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 E2 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 NCT00713778, 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 18 Aug 2008.