Ovarian ReserveNCT01919333
Anti-Mullerian Hormone Changes After Laparoscopic Ovarian Cystectomy for Endometrioma Compared With the Non-ovarian Conditions
An observational study of Ovarian Reserve, run by Thammasat University at 1 site in Thailand.
Trial summary
This aim of the study is to evaluate the impact of endometrioma and laparoscopic cystectomy on ovarian reserve as measured by serum antimullerian hormone and to study the different effects of levels of serum antimullerian hormone between laparoscopic cystectomy and the non-ovarian pelvic surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Reserve
- How many people
- 56 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2012to Dec 2013
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Reproductive women , age 18- 45 years who undergo laparoscopic ovarian cystectomy or laparoscopic non- ovarian pelvic surgery
Who may be able to join
- • Participants must be between the ages of 18 - 45 during enter the study .
- Every participants have to completely understand the process of this study and have written informed consent .
- Having regular menstrual cycles (21-35 days) at the time of operation
- no evidence of any other endocrine disorders such as diabetes mellitus, thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, or adrenal insufficiency.
- undergo laparoscopic ovarian cystectomy or laparoscopic non- ovarian pelvic surgery for benign pelvic disease
- No previous history of adnexal surgery
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- No any suspicious findings of malignant ovarian diseases
- Never taking any medication such as oral pill and hormonal drugs within 3 months before the enrollment.
- pathological diagnosis of excised ovarian tissue confirm as endometriotic cyst in study group and other benign pelvic disease in control group
Who cannot join
- polycystic ovarian syndrome according to the Rotterdam criteria
- pathological report as the malignant diseases
- have operation conversion to open-laparotomy
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of medicine , Thammasat university
Rangsit City Municipality, Pathumthanee, 12120
Chamnan Tanprasertkul, 66896999240, chamnandoctor@gmail.com
About this study
This aim of the study is to evaluate the impact of endometrioma and laparoscopic cystectomy on ovarian reserve as measured by serum antimullerian hormone and to study the different effects of levels of serum antimullerian hormone between laparoscopic cystectomy and the non-ovarian pelvic surgery.
- Conditions
- Ovarian Reserve
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 |
|---|---|---|
| laparoscopic ovarian cystectomy | the group who laparoscopic ovarian cystectomy are performed for endometrioma | |
| laparoscopic non- ovarian pelvic surgery | the group whom laparoscopic non- ovarian pelvic surgery are performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum AMH 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 posted9 Aug 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian ReserveStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chamnan Tanprasertkul, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919333
- Sponsor's protocol ID
- MTU-OB-3-096/56
- Status last verified
- Aug 2013
- First submitted
- 6 Aug 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Mullerian Hormone Changes After Laparoscopic Ovarian Cystectomy for Endometrioma Compared With the Non-ovarian Conditions
- ClinicalTrials.gov ID
- NCT01919333
- Acronym / sponsor ID
- MTU-OB-3-096/56
- Conditions
- Ovarian Reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- First posted
- 9 Aug 2013 (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.
This aim of the study is to evaluate the impact of endometrioma and laparoscopic cystectomy on ovarian reserve as measured by serum antimullerian hormone and to study the different effects of levels of serum antimullerian hormone between laparoscopic cystectomy and the non-ovarian pelvic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic ovarian cystectomy | – | –the group who laparoscopic ovarian cystectomy are performed for endometrioma |
| laparoscopic non- ovarian pelvic surgery | – | –the group whom laparoscopic non- ovarian pelvic surgery are performed |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Reproductive women , age 18- 45 years who undergo laparoscopic ovarian cystectomy or laparoscopic non- ovarian pelvic surgery
Key inclusion criteria (9 listed)
- • Participants must be between the ages of 18 - 45 during enter the study .
Key exclusion criteria (3 listed)
- polycystic ovarian syndrome according to the Rotterdam criteria
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
Serum AMH levels
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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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.
Faculty of medicine , Thammasat university
Rangsit City Municipality, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Reserve, run by Thammasat University at 1 site in Thailand.
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 9 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 9 Aug 2013. 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 Thailand. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum AMH levels (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 9 Aug 2013.