- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01919333
Anti-Mullerian Hormone Changes After Laparoscopic Ovarian Cystectomy for Endometrioma Compared With the Non-ovarian Conditions
August 6, 2013 updated by: Chamnan Tanprasertkul, Thammasat University
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 Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
56
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pathumthanee
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Rangsit, Pathumthanee, Thailand, 12120
- Recruiting
- Faculty of medicine , Thammasat university
-
Contact:
- Chamnan Tanprasertkul
- Phone Number: 66896999240
- Email: chamnandoctor@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Reproductive women , age 18- 45 years who undergo laparoscopic ovarian cystectomy or laparoscopic non- ovarian pelvic surgery
Description
Inclusion Criteria:
• 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
- 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
Exclusion Criteria:
polycystic ovarian syndrome according to the Rotterdam criteria
- pathological report as the malignant diseases
- have operation conversion to open-laparotomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum AMH levels
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
August 6, 2013
First Submitted That Met QC Criteria
August 6, 2013
First Posted (Estimate)
August 9, 2013
Study Record Updates
Last Update Posted (Estimate)
August 9, 2013
Last Update Submitted That Met QC Criteria
August 6, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- MTU-OB-3-096/56
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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