Back to resultsEffect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
depot medroxyprogesterone acetate
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
Inclusion Criteria:
- Healthy women 18-40 years old
- A diagnosis of endometrioma with diameter of at least 3 cm.
- Candidates for laparoscopic cystectomy
Exclusion Criteria:
- Patients' refusal to participate
- Not candidate for depot medroxyprogesterone acetate such as: cirrhosis, chronic kidney disease, venous thrombosis
- Use of estrogen-suppressive drugs in the preceding 3 months, such as:
Oral contraceptives, GnRH analogues, Progestins, Danazol
- Pathology report present no endometriosis
Sites / Locations
- Department of Obstetrics and Gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
depot medroxyprogesterone acetate
No depot medroxyprogesterone acetate
Arm Description
Outcomes
Primary Outcome Measures
Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01791413
Brief Title
Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic cystectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
depot medroxyprogesterone acetate
Arm Type
Active Comparator
Arm Title
No depot medroxyprogesterone acetate
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
depot medroxyprogesterone acetate
Intervention Description
DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
Primary Outcome Measure Information:
Title
Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation
Time Frame
Within the first 2 weeks and 3 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy women 18-40 years old
A diagnosis of endometrioma with diameter of at least 3 cm.
Candidates for laparoscopic cystectomy
Exclusion Criteria:
Patients' refusal to participate
Not candidate for depot medroxyprogesterone acetate such as: cirrhosis, chronic kidney disease, venous thrombosis
Use of estrogen-suppressive drugs in the preceding 3 months, such as:
Oral contraceptives, GnRH analogues, Progestins, Danazol
Pathology report present no endometriosis
Facility Information:
Facility Name
Department of Obstetrics and Gynecology
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas
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