EndometriosisNCT01065168
Serial Measurement of Serum Antimullerian Hormone in Women Undergoing Laparoscopic Cystectomy of Endometrioma
An observational study of Endometriosis, run by Mahidol University.
Trial summary
The purpose of this trial is to study ovarian reserve after laparoscopic endometrioma cystectomy by measuring antimullerian hormone. The measurements were measured before the surgery and one week and three months after the surgery. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Mar 2010
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: ovarian endometrioma performed laparoscopic cystectomy
Who may be able to join
- 20-40 years
- ovarian endometrioma > or = 3 cms
- laparoscopic cystectomy treatment
Who cannot join
- previous ovarian surgery
- other ovarian pathology
- previous drugs or hormonal treatment for endometrioma
About this study
The purpose of this trial is to study ovarian reserve after laparoscopic endometrioma cystectomy by measuring antimullerian hormone. The measurements were measured before the surgery and one week and three months after the surgery.
Read the detailed description
Antimullerian hormone will be obtained in patients with ovarian endometrioma before laparoscopic cystectomy is done. The measurements were compared with antimullerian hormone after one week and three months after the surgery. Forty three patients will be included in this study.
- Conditions
- Endometriosis
- Keywords
- endometriosis, endometrioma, antimullerian hormone, cystectomy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| endometrioma | ovarian endometrioma undergoing cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve before and after ovarian endometrioma cystectomy.
Measured: one week and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2010 (estimated)
- Study completionMar 2010 (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 Mahidol 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Singpetch Suksompong, Doctor, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065168
- Sponsor's protocol ID
- si637/2008
- Status last verified
- Jan 2009
- First submitted
- 6 Feb 2010
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Measurement of Serum Antimullerian Hormone in Women Undergoing Laparoscopic Cystectomy of Endometrioma
- ClinicalTrials.gov ID
- NCT01065168
- Acronym / sponsor ID
- si637/2008
- Conditions
- Endometriosis
- Keywords
- endometriosis, endometrioma, antimullerian hormone, cystectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 9 Feb 2010 (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.
The purpose of this trial is to study ovarian reserve after laparoscopic endometrioma cystectomy by measuring antimullerian hormone. The measurements were measured before the surgery and one week and three months after the surgery.
Detailed description
Antimullerian hormone will be obtained in patients with ovarian endometrioma before laparoscopic cystectomy is done. The measurements were compared with antimullerian hormone after one week and three months after the surgery. Forty three patients will be included in this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endometrioma | – | –ovarian endometrioma undergoing cystectomy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ovarian endometrioma performed laparoscopic cystectomy
Key inclusion criteria (3 listed)
- 20-40 years
- ovarian endometrioma > or = 3 cms
- laparoscopic cystectomy treatment
Key exclusion criteria (3 listed)
- previous ovarian surgery
- other ovarian pathology
- previous drugs or hormonal treatment for endometrioma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ovarian reserve before and after ovarian endometrioma cystectomy.
Time frame: one week and three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
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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.
Singpetch Suksompong, Doctor principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Mahidol 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 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: status not confirmed, as of the sponsor's last update on 17 Feb 2010. 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?
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?
Ovarian reserve before and after ovarian endometrioma cystectomy. (time frame: one week and three 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 17 Feb 2010.