EndometriomaSOAVE-1NCT03788720
Suture of the Ovary After Enucleation of Ovarian Endometrioma
A study testing Suture of the ovarian cortex and No suture of the ovarian cortex in people with Endometrioma, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity. According to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Endometrioma
- What is being tested?
- Suture of the ovarian cortex and No suture of the ovarian cortex
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- May 2023to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women affected by one primary (no recurrent) monolateral ovarian endometrioma, with maximum diameter between 5 and 10 cm, undergoing laparoscopic enucleation by stripping technique;
- Normal AFC at the enrollment (baseline).
Who cannot join
- Any other disease;
- Bilateral endometriomas;
- Deep infiltrating endometriosis;
- No previous pelvic surgery (even not gynecological);
- Any other pharmacologic and non pharmacologic treatment in the previous 3 months (wash-out period);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
"Filippo Del Ponte" Hospital
Varese, 21100
Antonio Simone Laganà, M.D., +393296279579, antoniosimone.lagana@asst-settelaghi.it
Davide Sturla, M.D.
About this study
Official title: Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma
Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity.
According to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed directly to Assisted Reproduction Technology (ART); conversely, for infertile women with endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in order to improve reproductive outcomes (both spontaneous and ART pregnancy rate).
Read more
To date, literature data do not allow to draw a firm conclusion about the best strategy to reduce ovarian damage during enucleation of ovarian endometriomas: in particular, investigators still lack robust evidence in order to choose between suturing the ovary or not after the enucleation.
In this scenario, the aim of our the study will be to compare functional outcomes of the ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.
- Conditions
- Endometrioma
- Being tested
- Suture of the ovarian cortex, No suture of the ovarian cortex
- Keywords
- Endometrioma, Laparoscopy, Suture, Ovary
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture of the ovarian cortexProcedure or surgery
Suture of the ovarian cortex after laparoscopic enucleation of endometriomas, using one single monofilament suture material, continuous suture technique with maximum 5 transfixion of the ovarian cortex and intracorporeal knots only (no extracorporeal knots).
No suture of the ovarian cortexProcedure or surgery
Laparoscopic enucleation of endometriomas without suture of the ovarian cortex
| Study group | Role | What they receive |
|---|---|---|
| Suture | Experimental | Women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas. Receives: Procedure: Suture of the ovarian cortex |
| No suture | Sham comparator | Women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex. Receives: Procedure: No suture of the ovarian cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antral Follicle Count (AFC)
AFC will be evaluated on day 3 of the cycle by a transvaginal ultrasound. Initially the ovarian volume of both the ovaries is calculated. Further the number of small antral follicles in both the ovaries is measured. These follicles could vary in size from 2-10 mm.
Measured: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
Secondary outcomes (3)
Pulsatility index, evaluated by Doppler flowmetry, of the ovarian artery
Evaluation of the pulsatility index (PI; minimum: 0; maximum: 7; higher values represent a better outcome) of the ovarian artery.
Measured: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
Resistive index, evaluated by Doppler flowmetry, of the ovarian artery
Evaluation of the resistive index (RI minimum: 0; maximum: 3; higher values represent a worse outcome) of the ovarian artery.
Measured: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
Ovarian volume
Evaluation of the ovarian volume calculated using the prolate ellipsoid formula (length x height x width x 0.523)
Measured: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study startMay 2023 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriomaStudies 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
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Antonio Simone Laganà, M.D., Principal investigator, Università degli Studi dell'InsubriaFabio Ghezzi, M.D., Study director, Università degli Studi dell'InsubriaJvan Casarin, M.D., Principal investigator, Università degli Studi dell'InsubriaSimone Garzon, Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788720
- Sponsor's protocol ID
- SOAVE-1
- Acronym
- SOAVE-1
- Status last verified
- Apr 2021
- First submitted
- 11 Oct 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma
- ClinicalTrials.gov ID
- NCT03788720
- Acronym / sponsor ID
- SOAVE-1 / SOAVE-1
- Conditions
- Endometrioma
- Keywords
- Endometrioma, Laparoscopy, Suture, Ovary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Dec 2018 (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.
Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity.
According to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed directly to Assisted Reproduction Technology (ART); conversely, for infertile women with endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in order to improve reproductive outcomes (both spontaneous and ART pregnancy rate).
To date, literature data do not allow to draw a firm conclusion about the best strategy to reduce ovarian damage during enucleation of ovarian endometriomas: in particular, investigators still lack robust evidence in order to choose between suturing the ovary or not after the enucleation.
In this scenario, the aim of our the study will be to compare functional outcomes of the ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Suture | Experimental | Procedure: Suture of the ovarian cortexWomen undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas. |
| No suture | Sham comparator | Procedure: No suture of the ovarian cortexWomen undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women affected by one primary (no recurrent) monolateral ovarian endometrioma, with maximum diameter between 5 and 10 cm, undergoing laparoscopic enucleation by stripping technique;
- Normal AFC at the enrollment (baseline).
Key exclusion criteria (5 listed)
- Any other disease;
- Bilateral endometriomas;
- Deep infiltrating endometriosis;
- No previous pelvic surgery (even not gynecological);
- Any other pharmacologic and non pharmacologic treatment in the previous 3 months (wash-out period);
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 |
|---|---|---|
| Suture of the ovarian cortexSuture of the ovarian cortex after laparoscopic enucleation of endometriomas, using one single monofilament suture material, continuous suture technique with maximum 5 transfixion of the ovarian cortex and intracorporeal knots only (no extracorporeal knots). | Procedure or surgery | Suture |
| No suture of the ovarian cortexLaparoscopic enucleation of endometriomas without suture of the ovarian cortex | Procedure or surgery | No suture |
Primary outcome
Antral Follicle Count (AFC)
Time frame: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
AFC will be evaluated on day 3 of the cycle by a transvaginal ultrasound. Initially the ovarian volume of both the ovaries is calculated. Further the number of small antral follicles in both the ovaries is measured. These follicles could vary in size from 2-10 mm.
3 secondary outcomes
Pulsatility index, evaluated by Doppler flowmetry, of the ovarian artery
Time frame: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
Resistive index, evaluated by Doppler flowmetry, of the ovarian artery
Time frame: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
Ovarian volume
Time frame: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Antonio Simone Laganà, M.D. principal investigator
Università degli Studi dell'Insubria
Fabio Ghezzi, M.D. study director
Università degli Studi dell'Insubria
Jvan Casarin, M.D. principal investigator
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture of the ovarian cortex and No suture of the ovarian cortex in people with Endometrioma, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 2 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: opening soon, as of the sponsor's last update on 29 Apr 2021. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Simone Laganà, M.D. (+393296279579, antoniosimone.lagana@asst-settelaghi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antral Follicle Count (AFC) (time frame: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery). 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 29 Apr 2021.