EndometriomaEnTOFNCT04452123
Endometrioma Treatment and Ovarian Function
A study testing Laparoscopic argon plasma treatment of endometrioma and Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary in people with Endometrioma, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Ovarian endometriosis (endometrioma) can be a cause of subfertility. According to European Society of Human Reproduction and Embryology (ESHRE) guidelines, surgery for endometrioma is recommended when an endometrioma is more than 3 cm in diameter because this management is associated with better spontaneous conception… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Endometrioma
- What is being tested?
- Laparoscopic argon plasma treatment of endometrioma and Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2020to 31 Dec 2023
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with endometrioma 3cm and more in diameter
Who cannot join
- using hormonal contraception or other hormonal treatment last 6 months
- suffer with polycystic ovarian syndrome
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Departement of gynecology and obstetrics, University hospital in Pilsen
Pilsen, 30408
Jan Humplik, MD, 420377105240, humplikj@fnplzen.cz
About this study
Ovarian endometriosis (endometrioma) can be a cause of subfertility. According to European Society of Human Reproduction and Embryology (ESHRE) guidelines, surgery for endometrioma is recommended when an endometrioma is more than 3 cm in diameter because this management is associated with better spontaneous conception rates. Nevertheless, surgery can also be potentially associated with a risk of destruction of functional ovarian tissue and reduction in ovarian reserve.
Anti-müllerian hormone (AMH) is a member of the Transforming Growth Factor beta family and is expressed by the small (<8 mm) pre-antral and early antral follicles. The AMH level reflects the size of the primordial follicle pool, and may be the best biochemical marker of ovarian function across an array of clinical situations Its level in serum is almost stable between 20 and 35 years of the woman´s life, unless using hormonal contraception and / or they suffer with Polycystic ovarian syndrome (PCOS). The level of AMH is also a useful indicator for the prediction chances of success of spontaneous or assisted conceptions. However, there paucity of data regarding changes in serum levels of AMH following surgery for endometrioma.
Read more
An alternative way for estimating ovarian reserve is quantifying ovarian mass with using standard 3D transvaginal ultrasound calculation (OVM) and assessment of antral follicular count.
The gold standard of endometrioma surgery is laparoscopic excision with suture or gentle coagulation of the rest of ovary or by the use of laparoscopic treatment with argon plasma energy.
- Conditions
- Endometrioma
- Being tested
- Laparoscopic argon plasma treatment of endometrioma, Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary
- Keywords
- Endometrioma, AMH
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic argon plasma treatment of endometriomaProcedure or surgery
Laparoscopic Argon Plasma vaporising the endometriotic cyst lining only until haemosiderin pigment stained tissue is no longer visible
Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovaryProcedure or surgery
Laparoscopic dissecting of capsule of endometrioma and achieving hemostasis with suture of rest of the ovary or with gentle coagulation.
| Study group | Role | What they receive |
|---|---|---|
| Argon plasma | Experimental | Patients with endometrioma treated with laparoscopic argon plasma energy. Receives: Procedure: Laparoscopic argon plasma treatment of endometrioma; Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary |
| Stripping and suture/coagulation | Experimental | Patients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary. Receives: Procedure: Laparoscopic argon plasma treatment of endometrioma; Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH
Changing of anti-müllerian hormon assay postop. in µg/L
Measured: 3 days,3-5 week postop., 3 months postop., 1 year (optional)
Antral follicle count (AFC)
Ultrasound count of Antral follicles after the surgery, counted 3-5. day of menstrual cycle
Measured: 3 months, 1 year
Both ovarian volume
Ultrasound volume of both ovaries in cm^3, measured 3-5. day of menstrual cycle
Measured: 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Humplik, MD, Charles University, Czech Republic
- Investigators
- Jan Humplik, MD, Principal investigator, Charles university in Pilsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452123
- Sponsor's protocol ID
- GPKENDO2001
- Acronym
- EnTOF
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 30 Jun 2020
- 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 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrioma Treatment and Ovarian Function
- ClinicalTrials.gov ID
- NCT04452123
- Acronym / sponsor ID
- EnTOF / GPKENDO2001
- Conditions
- Endometrioma
- Keywords
- Endometrioma, AMH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Jun 2020 (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.
Ovarian endometriosis (endometrioma) can be a cause of subfertility. According to European Society of Human Reproduction and Embryology (ESHRE) guidelines, surgery for endometrioma is recommended when an endometrioma is more than 3 cm in diameter because this management is associated with better spontaneous conception rates. Nevertheless, surgery can also be potentially associated with a risk of destruction of functional ovarian tissue and reduction in ovarian reserve.
Anti-müllerian hormone (AMH) is a member of the Transforming Growth Factor beta family and is expressed by the small (<8 mm) pre-antral and early antral follicles. The AMH level reflects the size of the primordial follicle pool, and may be the best biochemical marker of ovarian function across an array of clinical situations Its level in serum is almost stable between 20 and 35 years of the woman´s life, unless using hormonal contraception and / or they suffer with Polycystic ovarian syndrome (PCOS). The level of AMH is also a useful indicator for the prediction chances of success of spontaneous or assisted conceptions. However, there paucity of data regarding changes in serum levels of AMH following surgery for endometrioma.
An alternative way for estimating ovarian reserve is quantifying ovarian mass with using standard 3D transvaginal ultrasound calculation (OVM) and assessment of antral follicular count.
The gold standard of endometrioma surgery is laparoscopic excision with suture or gentle coagulation of the rest of ovary or by the use of laparoscopic treatment with argon plasma energy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Argon plasma | Experimental | Procedure: Laparoscopic argon plasma treatment of endometrioma, Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovaryPatients with endometrioma treated with laparoscopic argon plasma energy. |
| Stripping and suture/coagulation | Experimental | Procedure: Laparoscopic argon plasma treatment of endometrioma, Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovaryPatients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with endometrioma 3cm and more in diameter
Key exclusion criteria (2 listed)
- using hormonal contraception or other hormonal treatment last 6 months
- suffer with polycystic ovarian syndrome
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 argon plasma treatment of endometriomaLaparoscopic Argon Plasma vaporising the endometriotic cyst lining only until haemosiderin pigment stained tissue is no longer visible | Procedure or surgery | Argon plasma, Stripping and suture/coagulation |
| Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovaryLaparoscopic dissecting of capsule of endometrioma and achieving hemostasis with suture of rest of the ovary or with gentle coagulation. | Procedure or surgery | Argon plasma, Stripping and suture/coagulation |
Primary outcome
AMH
Time frame: 3 days,3-5 week postop., 3 months postop., 1 year (optional)
Changing of anti-müllerian hormon assay postop. in µg/L
Antral follicle count (AFC)
Time frame: 3 months, 1 year
Ultrasound count of Antral follicles after the surgery, counted 3-5. day of menstrual cycle
Both ovarian volume
Time frame: 3 months, 1 year
Ultrasound volume of both ovaries in cm^3, measured 3-5. day of menstrual cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- 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. This study is not recruiting at the moment.
Jan Humplik, MD principal investigator
Charles university in Pilsen
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 argon plasma treatment of endometrioma and Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary in people with Endometrioma, run by Charles University, Czech Republic at 1 site in Czechia.
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 2 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: status not confirmed, as of the sponsor's last update on 30 Jun 2020. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Humplik, MD (420377105254, humplikj@fnplzen.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH (time frame: 3 days,3-5 week postop., 3 months postop., 1 year (optional)). The study lists 3 primary outcomes in all. 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 30 Jun 2020.