Cyst OvaryNCT03109964
The Affect of Hemostasis Technique During Laparoscopic Ovarian Cystectomy on Future Fertility
A study testing Bipolar coagulation forceps (ETHICON inc.) and SURGIFLO hemostatic matrix (ETHICON inc.) in people with Cyst Ovary, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Cyst Ovary
- What is being tested?
- Bipolar coagulation forceps (ETHICON inc.) and SURGIFLO hemostatic matrix (ETHICON inc.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Nov 2018to 1 Aug 2022
- Phase
- Interventional
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients with benign ovarian cysts that are interested in future fertility ages 18-44.
Who cannot join
- Female patients with malignant ovarian cysts/masses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Affect of Hemostasis With Bipolar Coagulation Versus SURGIFLO Placement on Ovarian Reserve and Future Fertility
Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2), Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian volume and antral follicle count.
Read the detailed description
Patients undergoing elective laparoscopic ovarian cystectomy will be recruited after signing an informed consent, and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including FSH, LH, E2, Progesterone and AMH levels, and sonographic evaluation of ovarian volume and antral follicle count.
Antral follicle count will be performed on the cyst post-surgery using light microscopy. The difference in hormone levels, especially AMH reflects the damage done during surgery to the ovarian reserve. Sonographic signs including a decrease in ovarian volume and antral follicle count also reflect the damage done during surgery to the ovarian reserve.
- Conditions
- Cyst Ovary
- Being tested
- Bipolar coagulation forceps (ETHICON inc.), SURGIFLO hemostatic matrix (ETHICON inc.)
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar coagulation forceps (ETHICON inc.)Device
Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.
SURGIFLO hemostatic matrix (ETHICON inc.)Device
Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.
| Study group | Role | What they receive |
|---|---|---|
| Hemostasis with bipolar coagulation | Active comparator | Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis. Receives: Device: Bipolar coagulation forceps (ETHICON inc.) |
| Hemostasis with SURGIFLO | Experimental | Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis. Receives: Device: SURGIFLO hemostatic matrix (ETHICON inc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in ovarian reserve.
Decline rate of AMH levels before and 6 months after surgery.
Measured: Up to 6 months.
Secondary outcomes (7)
Sonographic decline in ovarian volume
Decline rate of ovarian volume before and 6 months after surgery.
Measured: Up to 6 months
Sonographic decline in ovarian antral follicle count
Decline rate of ovarian antral follicle count before and 6 months after surgery.
Measured: Up to 6 months
Changes in FSH levels
Changes in FSH levels before and 6 months after surgery.
Measured: Up to 6 months.
Changes in LH levels
Changes in LH levels before and 6 months after surgery.
Measured: Up to 6 months
Changes in Progesterone levels
Changes in Progesterone levels before and 6 months after surgery.
Measured: Up to 6 months
Changes in E2 levels
Changes in E2 levels before and 6 months after surgery.
Measured: Up to 6 months
Number of antral follicles in the cyst removed from the ovary.
Number of antral follicles in the cyst removed from the ovary as seen utilizing light microscopy.
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start20 Nov 2018
- Primary completion31 Mar 2021
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyst OvaryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109964
- Sponsor's protocol ID
- 0232-17-RMB
- Status last verified
- Oct 2022
- First submitted
- 29 Mar 2017
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affect of Hemostasis With Bipolar Coagulation Versus SURGIFLO Placement on Ovarian Reserve and Future Fertility
- ClinicalTrials.gov ID
- NCT03109964
- Acronym / sponsor ID
- 0232-17-RMB
- Conditions
- Cyst Ovary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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.
Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2), Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian volume and antral follicle count.
Detailed description
Patients undergoing elective laparoscopic ovarian cystectomy will be recruited after signing an informed consent, and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including FSH, LH, E2, Progesterone and AMH levels, and sonographic evaluation of ovarian volume and antral follicle count.
Antral follicle count will be performed on the cyst post-surgery using light microscopy. The difference in hormone levels, especially AMH reflects the damage done during surgery to the ovarian reserve. Sonographic signs including a decrease in ovarian volume and antral follicle count also reflect the damage done during surgery to the ovarian reserve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemostasis with bipolar coagulation | Active comparator | Device: Bipolar coagulation forceps (ETHICON inc.)Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis. |
| Hemostasis with SURGIFLO | Experimental | Device: SURGIFLO hemostatic matrix (ETHICON inc.)Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients with benign ovarian cysts that are interested in future fertility ages 18-44.
Key exclusion criteria (1 listed)
- Female patients with malignant ovarian cysts/masses.
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 |
|---|---|---|
| Bipolar coagulation forceps (ETHICON inc.)Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device. | Device | Hemostasis with bipolar coagulation |
| SURGIFLO hemostatic matrix (ETHICON inc.)Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO. | Device | Hemostasis with SURGIFLO |
Primary outcome
Decline in ovarian reserve.
Time frame: Up to 6 months.
Decline rate of AMH levels before and 6 months after surgery.
7 secondary outcomes
Sonographic decline in ovarian volume
Time frame: Up to 6 months
Sonographic decline in ovarian antral follicle count
Time frame: Up to 6 months
Changes in FSH levels
Time frame: Up to 6 months.
Changes in LH levels
Time frame: Up to 6 months
Changes in Progesterone levels
Time frame: Up to 6 months
Changes in E2 levels
Time frame: Up to 6 months
Number of antral follicles in the cyst removed from the ovary.
Time frame: Up to 6 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 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Cyst Ovary
RecruitingObservational study
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
Gynecologic Disease, Gynecologic Cancer
Recruiting
Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy
Endometriotic Cyst of Ovary
RecruitingObservational study
Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
Ovarian Neoplasms, Ovary Cancer
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.
Roy Lauterbach, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar coagulation forceps (ETHICON inc.) and SURGIFLO hemostatic matrix (ETHICON inc.) in people with Cyst Ovary, run by Rambam Health Care Campus at 1 site in Israel.
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 1 inclusion and 1 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 Oct 2022. 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 Israel. 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.
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?
Decline in ovarian reserve. (time frame: Up to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.