Endometriosis
Conditions
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.
Interventions
DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation | Within the first 2 weeks and 3 months after surgery |
Countries
Thailand
Participant flow
Recruitment details
Mar.2012-Feb.2013 University Hospital
Pre-assignment details
Assessed for eligibility n=60 Excluded n=20 (15=not compatible with inclusion criteria 5=denied to participate)
Participants by arm
| Arm | Count |
|---|---|
| No Depot Medroxyprogesterone Acetate | 19 |
| Depot Medroxyprogesterone Acetate depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks) | 15 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 1 |
Baseline characteristics
| Characteristic | Depot Medroxyprogesterone Acetate | No Depot Medroxyprogesterone Acetate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 19 Participants | 34 Participants |
| Age Continuous | 32.46 years STANDARD_DEVIATION 6.46 | 32.57 years STANDARD_DEVIATION 5.67 | 32.53 years STANDARD_DEVIATION 6.13 |
| Region of Enrollment Thailand | 15 participants | 19 participants | 34 participants |
| Sex: Female, Male Female | 15 Participants | 19 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2 wk Post op : No Depot Medroxyprogesterone Acetate | Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation | -56.86 percentage of serum AMH change |
| 2 wk Post op:Depot Medroxyprogesterone Acetate | Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation | -77.72 percentage of serum AMH change |
| 3 mo. Post op: No Depot Medroxyprogesterone Acetate | Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation | -36.69 percentage of serum AMH change |
| 3 mo. Post op: Depot Medroxyprogesterone Acetate | Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation | -66.84 percentage of serum AMH change |