Ovarian CystsNCT05054946
The Effect of Laparoscopic Surgery on Ovarian Reserve According to Cyst Types
A study testing Laparoscopic cystectomy in people with Ovarian Cysts, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to compare the effect of laparoscopic ovarian cystectomy on ovarian reserve in terms of different cyst types. 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?
- Laparoscopic cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Sep 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- no ovarian surgery before
Who cannot join
- Endocrinological pathologies
- Suspicion of malignancy in preoperative laboratory and ultrasonographic evaluations
- Detection of malignancy in histopathological examination
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to compare the effect of laparoscopic ovarian cystectomy on ovarian reserve in terms of different cyst types.
Read the detailed description
Participants who will be treated surgically for ovarian cysts will be included in the study. Anti-Mullerian Hormone (AMH) levels of the participants will be investigated before the surgery and 6 months after the surgery. All surgeries will be performed under general anesthesia laparoscopically. After histopathological evaluation, the participants will be divided into three groups; Group 1: Endometrioma, Group 2: Mature cystic teratoma (Dermoid cyst) and Group 3: Serous or mucinous cystadenoma.
A total of fifty-five women will be included in the study.
- Conditions
- Ovarian Cysts
- Being tested
- Laparoscopic cystectomy
- Keywords
- ovarian reserve, anti-mullerian hormone, ovarian cyst
- 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 cystectomyProcedure or surgery
All surgeries will be performed under general anesthesia by laparoscopically.
| Study group | Role | What they receive |
|---|---|---|
| Endometrioma | Active comparator | Participants who will have endometrioma after histopathological evaluation. Receives: Procedure: Laparoscopic cystectomy |
| Mature cystic teratoma (dermoid cyst) | Active comparator | Participants who will have mature cystic teratoma (dermoid cyst) after histopathological evaluation. Receives: Procedure: Laparoscopic cystectomy |
| Serous or mucinous cystadenoma | Active comparator | Participants who will have serous or mucinous cystadenoma after histopathological evaluation. Receives: Procedure: Laparoscopic cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AMH Level
AMH levels of the participants will be investigated before the surgery and 6 months after the surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Oct 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CystsStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahattin Anıl Arı, Ege University
- Investigators
- Sabahattin Anil Ari, MD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054946
- Sponsor's protocol ID
- 17/056
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2021
- Last updated
- 7 Sep 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 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laparoscopic Surgery on Ovarian Reserve According to Cyst Types
- ClinicalTrials.gov ID
- NCT05054946
- Acronym / sponsor ID
- 17/056
- Conditions
- Ovarian Cysts
- Keywords
- ovarian reserve, anti-mullerian hormone, ovarian cyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 23 Sep 2021 (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 aim of our study is to compare the effect of laparoscopic ovarian cystectomy on ovarian reserve in terms of different cyst types.
Detailed description
Participants who will be treated surgically for ovarian cysts will be included in the study. Anti-Mullerian Hormone (AMH) levels of the participants will be investigated before the surgery and 6 months after the surgery. All surgeries will be performed under general anesthesia laparoscopically. After histopathological evaluation, the participants will be divided into three groups; Group 1: Endometrioma, Group 2: Mature cystic teratoma (Dermoid cyst) and Group 3: Serous or mucinous cystadenoma.
A total of fifty-five women will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endometrioma | Active comparator | Procedure: Laparoscopic cystectomyParticipants who will have endometrioma after histopathological evaluation. |
| Mature cystic teratoma (dermoid cyst) | Active comparator | Procedure: Laparoscopic cystectomyParticipants who will have mature cystic teratoma (dermoid cyst) after histopathological evaluation. |
| Serous or mucinous cystadenoma | Active comparator | Procedure: Laparoscopic cystectomyParticipants who will have serous or mucinous cystadenoma after histopathological evaluation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- no ovarian surgery before
Key exclusion criteria (3 listed)
- Endocrinological pathologies
- Suspicion of malignancy in preoperative laboratory and ultrasonographic evaluations
- Detection of malignancy in histopathological examination
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 cystectomyAll surgeries will be performed under general anesthesia by laparoscopically. | Procedure or surgery | Endometrioma, Mature cystic teratoma (dermoid cyst), Serous or mucinous cystadenoma |
Primary outcome
Change in AMH Level
Time frame: 6 months
AMH levels of the participants will be investigated before the surgery and 6 months after the surgery.
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 7 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cysts
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women With Complex Pelvic Adnexal Masses ≤ 8cm.
Ovarian Cancer, Ovarian Mass
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
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.
Sabahattin Anil Ari, MD principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cystectomy in people with Ovarian Cysts, run by Ege University at 1 site in Turkey (Türkiye).
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 3 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 7 Sep 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 Turkey (Türkiye). 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?
Change in AMH Level (time frame: 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 7 Sep 2022.