Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs. upfront surgery to save ovarian reserve in young women with ovarian endometrioma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Dienogest 2mg po qd
Placebo 1 table po qd
conservative surgery without intent to oophorectomy
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Compare the mean change of serum Anti-Mullerian Hormone (AMH) level
Time frame: 3 month after surgery
Compare the mean change of serum AMH level
Time frame: 1 month after surgery
Compare the trend of mean change of serum AMH level
Time frame: 1 and 3 month after surgery
Compare the mean change of serum AMH level
Time frame: baseline and after preoperative dienogest/placebo therapy for 3 months
Compare the revised American fertility society (AFS) score
Time frame: At surgery
compare the surgical time (minute)
surgical time (minute)
Time frame: intraoperative
Brief Pain Inventory (BPI) scores
Time frame: baseline, 1 month after surgery and 3 month after surgery
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: All adverse events from randomization to postoperative 3 months
Mean change of diameter of endometrioma measured by ultrasonography after preoperative dienogest/placebo therapy for 3months
Time frame: baseline and after preoperative dienogest/placebo therapy for 3 months
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