EndometriosisNCT02685644
Association Between Laparoscopic Removal of Endometriomas and Anti-mullerian Hormone Levels
An observational study of Endometriosis and Ovarian Reserve, run by Ankara University.
Trial summary
Laparoscopic excision of endometriotic cysts is the main stream surgical intervention for treatment of endometriosis. However there is evidence that intervention may effect ovarian reserve by destruction of healthy ovarian tissue during surgery. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Ovarian Reserve
- What is being tested?
- Laparoscopic removal of cysts
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2018
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This study will recruit healthy women besides having endometrioma cysts who will undergo laparoscopic removal of such lesions.
Who may be able to join
- Women with endometrioma cyst(s)
- Women of age under 35 years old
- Women without any previous ovarian surgery
Who cannot join
- Combined oral contraceptive or long term GnRH (gonadotropin-releasing hormone) analog use in the preceding 3 months to enrolment
- Having another cystic lesion besides endometrioma
- Need for extensive bipolar coagulation during surgery
- Any anatomical problem preventing evaluation of ovaries with high-resolution ultrasound
- Postoperative pathology excluding endometrioma
Trial locations and contacts
No sites are listed yet.
Erkan Kalafat contact
About this study
Official title: Effects of Laparoscopic Endometrioma Removal on Anti-mullerian Hormone Levels
Laparoscopic excision of endometriotic cysts is the main stream surgical intervention for treatment of endometriosis. However there is evidence that intervention may effect ovarian reserve by destruction of healthy ovarian tissue during surgery. Available evidence on the topic are contradictory and employed research methodology are diverse. There is need for an adequately powered research with proper methodology to assess actual effects of surgery.
- Conditions
- Endometriosis, Ovarian Reserve
- Being tested
- Laparoscopic removal of cysts
- Keywords
- endometrioma, laparoscopy, anti-mullerian hormone, ovarian reserve
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic removal of cystsProcedure or surgery
Women with endometrioma lesions will undergo laparoscopic removal. Cysts will be enucleated with blunt dissection of the cyst capsule and following traction, counter traction maneuver. Bipolar coagulation will be used sparsely and suturing will be the predominant choice for achieving bleeding control.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic removal | Patients with endometrioma who will undergo laparoscopic removal of cysts. Receives: Procedure: Laparoscopic removal of cysts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Mullerian hormone levels
AMH (anti-mullerian hormone) levels will be measured before surgery and during various time points up to 1 year after the surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Kalafat, Ankara University
- Investigators
- Erkan Kalafat, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685644
- Sponsor's protocol ID
- 07
- Status last verified
- Feb 2016
- First submitted
- 15 Feb 2016
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Laparoscopic Endometrioma Removal on Anti-mullerian Hormone Levels
- ClinicalTrials.gov ID
- NCT02685644
- Acronym / sponsor ID
- 07
- Conditions
- Endometriosis, Ovarian Reserve
- Keywords
- endometrioma, laparoscopy, anti-mullerian hormone, ovarian reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Feb 2016 (estimated)
- 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.
Laparoscopic excision of endometriotic cysts is the main stream surgical intervention for treatment of endometriosis. However there is evidence that intervention may effect ovarian reserve by destruction of healthy ovarian tissue during surgery. Available evidence on the topic are contradictory and employed research methodology are diverse. There is need for an adequately powered research with proper methodology to assess actual effects of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic removal | – | Procedure: Laparoscopic removal of cystsPatients with endometrioma who will undergo laparoscopic removal of cysts. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will recruit healthy women besides having endometrioma cysts who will undergo laparoscopic removal of such lesions.
Key inclusion criteria (3 listed)
- Women with endometrioma cyst(s)
- Women of age under 35 years old
- Women without any previous ovarian surgery
Key exclusion criteria (5 listed)
- Combined oral contraceptive or long term GnRH (gonadotropin-releasing hormone) analog use in the preceding 3 months to enrolment
- Having another cystic lesion besides endometrioma
- Need for extensive bipolar coagulation during surgery
- Any anatomical problem preventing evaluation of ovaries with high-resolution ultrasound
- Postoperative pathology excluding endometrioma
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 removal of cystsWomen with endometrioma lesions will undergo laparoscopic removal. Cysts will be enucleated with blunt dissection of the cyst capsule and following traction, counter traction maneuver. Bipolar coagulation will be used sparsely and suturing will be the predominant choice for achieving bleeding control. | Procedure or surgery | Laparoscopic removal |
Primary outcome
Anti-Mullerian hormone levels
Time frame: 1 year
AMH (anti-mullerian hormone) levels will be measured before surgery and during various time points up to 1 year after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
Erkan Kalafat contact
Erkan Kalafat principal investigator
Ankara University
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Ovarian Reserve, run by Ankara University.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Erkan Kalafat (ekalafat@ankara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Mullerian hormone levels (time frame: 1 year). 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 19 Feb 2016.