EndometriosisNCT03484546
Optimum Menstrual Cycle Time for Endometrioma Excision
An observational study of Endometriosis and Endometrioma, run by Acibadem University at 3 sites in Turkey (Türkiye).
Trial summary
This study evaluates the optimum day of menstrual period for the excision of endometriomas to minimize the damage of surgery to normal ovarian tissue. Patients will be grouped as follicular, ovulatory and luteal according to menstrual days. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis, Endometrioma
- What is being tested?
- laparoscopic endometrioma cyst excision
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 26 Mar 2018to 1 Oct 2021
- Phase
- Observational
- 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
Study population: Women who admitted to out-patient clinic between the ages of 18-40 years,had 4-10cm ovarian unilateral endometrioma and had an indication of laparoscopic ovarian endometrioma excision.
Who may be able to join
- 4 to 10 cm unilateral ovarian endometrioma
- having clinically indication of laparoscopic ovarian endometrioma excision
Who cannot join
- prior gynecologic surgery
- prior abdominal surgery
- additional operation in the same session
- having the diagnosis of premature ovarian failure or ovarian insufficiency
- having any diagnosis of malignancy
- having diagnosis of a non-gynecologic chronicle disease
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Acibadem Fulya Hospital
Istanbul, 34457
Acibadem MAA University Atakent Hospital
Istanbul, 34457
Acibadem MAA University Maslak Hospital
Istanbul, 34457
About this study
This study evaluates the optimum day of menstrual period for the excision of endometriomas to minimize the damage of surgery to normal ovarian tissue. Patients will be grouped as follicular, ovulatory and luteal according to menstrual days. Ovarian damage will be evaluated with both pathologic examination and anti-mullerian hormone levels before and after the surgery.
Read the detailed description
Endometriosis is a common gynecologic disease seen in about 10% of women in reproductive age. The most common site of endometriosis is overt. Cystic formation of ovarian endometriosis is called endometrioma (chocolate cyst). Definitive treatment of endometriomas is excision by laparoscopy. The disadvantage of this surgery is the removal of some of the normal ovarian follicles within cystectomy material. This procedure can damage the ovarian reserves with the treatment of endometriomas, which are already the cause of infertility, and lead to the conditions such as infertility or early menopause. It has been understood that the ovarian reserves of the patients who underwent endometrioma cystectomy with the decrease of the Anti-Mullerian Hormone values, which is an over reserve parameter.
- Conditions
- Endometriosis, Endometrioma
- Being tested
- laparoscopic endometrioma cyst excision
- Keywords
- ovarian reserve, endometriosis, endometrioma
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic endometrioma cyst excisionProcedure or surgery
laparoscopic resection of ovarian endometrioma
| Study group | Role | What they receive |
|---|---|---|
| folicular | Women who will undergo endometrioma cystectomy in her follicular phase of menstrual period. Receives: Procedure: laparoscopic endometrioma cyst excision | |
| ovulatory | Women who will undergo endometrioma cystectomy in her ovulatory phase (12-14th day of mestrual period cycle for women regular period) of menstrual cycle. Receives: Procedure: laparoscopic endometrioma cyst excision | |
| luteal | Women who will undergo endometrioma cystectomy in her luteal phase of menstrual period. Receives: Procedure: laparoscopic endometrioma cyst excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of ovarian follicle damage via histological examination
Histologic evaluation of the cystectomy excision material for health ovarian follicles
Measured: 5 days after the surgery
Change of anti-mullerian hormone level 6 months after surgery
Comparison of pre-operative and 6 months after surgery of anti-mullerian hormone levels
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 posted2 Apr 2018
- Study start26 Mar 2018
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turgut Aydın, Acibadem University
- Investigators
- Ozguc Takmaz, Principal investigator, Acibadem MAA University Maslak Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484546
- Sponsor's protocol ID
- AcibademGynecology
- Status last verified
- Oct 2023
- First submitted
- 26 Mar 2018
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will be decided during the study process.
Publications
Takmaz O, Asoglu MR, Ceyhan M, Unsal G, Gungor M. Comparing ovarian reserve parameters after laparoscopic endometrioma resection in the follicular vs. luteal phase: a prospective cohort study. Front Med (Lausanne). 2024 Oct 15;11:1469858. doi: 10.3389/fmed.2024.1469858. eCollection 2024.
PubMed 39473503
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimum Menstrual Cycle Time for Endometrioma Excision
- ClinicalTrials.gov ID
- NCT03484546
- Acronym / sponsor ID
- AcibademGynecology
- Conditions
- Endometriosis, Endometrioma
- Keywords
- ovarian reserve, endometriosis, endometrioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 2 Apr 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.
This study evaluates the optimum day of menstrual period for the excision of endometriomas to minimize the damage of surgery to normal ovarian tissue. Patients will be grouped as follicular, ovulatory and luteal according to menstrual days. Ovarian damage will be evaluated with both pathologic examination and anti-mullerian hormone levels before and after the surgery.
Detailed description
Endometriosis is a common gynecologic disease seen in about 10% of women in reproductive age. The most common site of endometriosis is overt. Cystic formation of ovarian endometriosis is called endometrioma (chocolate cyst). Definitive treatment of endometriomas is excision by laparoscopy. The disadvantage of this surgery is the removal of some of the normal ovarian follicles within cystectomy material. This procedure can damage the ovarian reserves with the treatment of endometriomas, which are already the cause of infertility, and lead to the conditions such as infertility or early menopause. It has been understood that the ovarian reserves of the patients who underwent endometrioma cystectomy with the decrease of the Anti-Mullerian Hormone values, which is an over reserve parameter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| folicular | – | Procedure: laparoscopic endometrioma cyst excisionWomen who will undergo endometrioma cystectomy in her follicular phase of menstrual period. |
| ovulatory | – | Procedure: laparoscopic endometrioma cyst excisionWomen who will undergo endometrioma cystectomy in her ovulatory phase (12-14th day of mestrual period cycle for women regular period) of menstrual cycle. |
| luteal | – | Procedure: laparoscopic endometrioma cyst excisionWomen who will undergo endometrioma cystectomy in her luteal phase of menstrual period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who admitted to out-patient clinic between the ages of 18-40 years,had 4-10cm ovarian unilateral endometrioma and had an indication of laparoscopic ovarian endometrioma excision.
Key inclusion criteria (2 listed)
- 4 to 10 cm unilateral ovarian endometrioma
- having clinically indication of laparoscopic ovarian endometrioma excision
Key exclusion criteria (6 listed)
- prior gynecologic surgery
- prior abdominal surgery
- additional operation in the same session
- having the diagnosis of premature ovarian failure or ovarian insufficiency
- having any diagnosis of malignancy
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 endometrioma cyst excisionlaparoscopic resection of ovarian endometrioma | Procedure or surgery | folicular, luteal, ovulatory |
Primary outcome
Determination of ovarian follicle damage via histological examination
Time frame: 5 days after the surgery
Histologic evaluation of the cystectomy excision material for health ovarian follicles
Change of anti-mullerian hormone level 6 months after surgery
Time frame: 6 months
Comparison of pre-operative and 6 months after surgery of anti-mullerian hormone levels
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 24 Oct 2023.
- Derived from this study: PubMed 39473503Takmaz O, Asoglu MR, Ceyhan M, Unsal G, Gungor M. Comparing ovarian reserve parameters after laparoscopic endometrioma resection in the follicular vs. luteal phase: a prospective cohort study. Front Med (Lausanne). 2024 Oct 15;11:1469858. doi: 10.3389/fmed.2024.1469858. eCollection 2024.
- Individual participant dataSharing planned: Undecided. Data sharing will be decided during the study process.
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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.
Ozguc Takmaz principal investigator
Acibadem MAA University Maslak Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Endometrioma, run by Acibadem University at 3 sites 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 2 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: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Determination of ovarian follicle damage via histological examination (time frame: 5 days after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03484546, which also lists 1 linked publication.
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 24 Oct 2023.