Ovarian Cyst BenignNCT06852313
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents
A study testing Laparoscopic ovarian cyst surgery in people with Ovarian Cyst Benign, run by University Children's Hospital, Zurich at 2 sites in Switzerland.
Trial summary
The purpose of this study is to evaluate which operative technique should be used for managing simple ovarian cysts in girls and adolescents. The two techniques that are being compared are laparoscopic cyst enucleation and laparoscopic cyst deroofing. Read more about this study
- Who is it for?
- Ages 1 year to 18 years, women only
- Conditions the study is for
- Ovarian Cyst Benign
- What is being tested?
- Laparoscopic ovarian cyst surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 5 Feb 2026to 1 Dec 2028
- 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 1 year to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Symptomatic simple cysts ≥ 4 cm with indication for surgical intervention
- Asymptomatic cysts ≥ 4 cm, with surgical indication due to persistence or increase in size
- Asymptomatic cysts ≥ 4 cm with other pathology as surgical indication, if known preoperatively
- Age 12 months - 18 years
- Parents/legal custodian and patient give consent, for patients unable to consent due to their health condition or developmental status they show no signs of unwillingness to participate
- Symptomatic simple cysts ≥ 4 cm with indication for surgical intervention on both ovaries (each ovary will count as one)
Who cannot join
- Neonatal ovarian cysts (age <12 months)
- Age >18 years
- Complex cysts (with solid components, e.g., Teratoma, risk or suspicion of malignancy)
- Paratubar/paraovarian cysts
- Medical reason that precludes cyst enucleation (e.g. severe coagulopathy)
- Neither signed informed consent form or inadequate german, french or english language skills to give informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University Children's Hospital Basel
Basel
Ulrike Subotic, MD, +41617041212, ulrike.subotic@ukbb.ch
Ulrike Subotic, MD
- Recruiting
University Children's Hospital Zurich
Zurich
Uchenna Kennedy, MD, +412494949, uchenna.kennedy@kispi.uzh.ch
Uchenna Kennedy, MD
About this study
The purpose of this study is to evaluate which operative technique should be used for managing simple ovarian cysts in girls and adolescents. The two techniques that are being compared are laparoscopic cyst enucleation and laparoscopic cyst deroofing. The investigators will assess the effect of both techniques on the ovarian reserve and the risk of cyst recurrence.
- Conditions
- Ovarian Cyst Benign
- Being tested
- Laparoscopic ovarian cyst surgery
- Keywords
- Ovarian cyst, Laparoscopy, Child
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ovarian cyst surgeryProcedure or surgery
Laparoscopic ovarian cyst surgery is any surgery with the goal of removal or drainage of an ovarian cyst. The exact surgical technique will be predefined by randomization.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Cyst Deroofing | Experimental | The Ovarian cyst is deroofed with a specific, predefined technique: removal of a square of the cyst wall and overlying ovarian capsule of 16x16mm and suctioning of cyst contents. Receives: Procedure: Laparoscopic ovarian cyst surgery |
| Ovarian Cyst Enucleation | Experimental | The ovarian cyst is enucleated by complete removal of the cyst lining with preservation of surrounding ovarian tissue. Receives: Procedure: Laparoscopic ovarian cyst surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative change of AMH level
Change in AMH level postoperatively compared to preoperative AMH levels (measured in pmol/L).
Measured: 8 weeks
Secondary outcomes (1)
Postoperative recurrence rate
Postoperative recurrence is defined as an ipsilateral asymptomatic cyst ≥ 4cm or a cyst of any size that requires a medical or surgical intervention due to symptoms at follow-up 6-8 weeks postoperatively.
If the asymptomatic cyst is < 4cm, a second follow-up will be performed at 10-14 weeks postoperatively. Recurrence is then defined as ipsilateral asymptomatic cyst ≥ 4cm or a cyst of any size that requires a medical or surgical intervention due to symptoms.
The outcome will be measured as "recurrence/no recurrence"
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start5 Feb 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cyst BenignStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel
- Responsible party
- Principal investigator, Uchenna Kennedy, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852313
- Sponsor's protocol ID
- SAVEOVPRO2025
- Status last verified
- May 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06852313
- Acronym / sponsor ID
- SAVEOVPRO2025
- Conditions
- Ovarian Cyst Benign
- Keywords
- Ovarian cyst, Laparoscopy, Child
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 28 Feb 2025 (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.
The purpose of this study is to evaluate which operative technique should be used for managing simple ovarian cysts in girls and adolescents. The two techniques that are being compared are laparoscopic cyst enucleation and laparoscopic cyst deroofing. The investigators will assess the effect of both techniques on the ovarian reserve and the risk of cyst recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ovarian Cyst Deroofing | Experimental | Procedure: Laparoscopic ovarian cyst surgeryThe Ovarian cyst is deroofed with a specific, predefined technique: removal of a square of the cyst wall and overlying ovarian capsule of 16x16mm and suctioning of cyst contents. |
| Ovarian Cyst Enucleation | Experimental | Procedure: Laparoscopic ovarian cyst surgeryThe ovarian cyst is enucleated by complete removal of the cyst lining with preservation of surrounding ovarian tissue. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Symptomatic simple cysts ≥ 4 cm with indication for surgical intervention
- Asymptomatic cysts ≥ 4 cm, with surgical indication due to persistence or increase in size
- Asymptomatic cysts ≥ 4 cm with other pathology as surgical indication, if known preoperatively
- Age 12 months - 18 years
- Parents/legal custodian and patient give consent, for patients unable to consent due to their health condition or developmental status they show no signs of unwillingness to participate
Key exclusion criteria (6 listed)
- Neonatal ovarian cysts (age <12 months)
- Age >18 years
- Complex cysts (with solid components, e.g., Teratoma, risk or suspicion of malignancy)
- Paratubar/paraovarian cysts
- Medical reason that precludes cyst enucleation (e.g. severe coagulopathy)
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 cyst surgeryLaparoscopic ovarian cyst surgery is any surgery with the goal of removal or drainage of an ovarian cyst. The exact surgical technique will be predefined by randomization. | Procedure or surgery | Ovarian Cyst Deroofing, Ovarian Cyst Enucleation |
Primary outcome
Postoperative change of AMH level
Time frame: 8 weeks
Change in AMH level postoperatively compared to preoperative AMH levels (measured in pmol/L).
1 secondary outcome
Postoperative recurrence rate
Time frame: 14 weeks
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 28 Apr 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic ovarian cyst surgery in people with Ovarian Cyst Benign, run by University Children's Hospital, Zurich at 2 sites in Switzerland.
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 6 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
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 Uchenna Kennedy, MD (0041 2494949, uchenna.kennedy@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative change of AMH level (time frame: 8 weeks). 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 28 Apr 2026.