The primary research hypothesis of this study is that dihydroartemisinin is effective in restoration of regular menstrual cycles of PCOS subjects who meet at least two of three Rotterdam Criteria. Secondary research hypotheses include: dihydroartemisinin is also effective in reducing androgen, total immature follicles, and anti-Mullerian hormone.
Polycystic ovary syndrome (PCOS) is a common reproductive endocrine metabolic disorder caused by genetic and environmental factors. Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, artemisinin has also been reported to have significant anti-inflammatory, anti-tumor and immune-modulating effects. Our recent study revealed that artemisinin derivatives protect against PCOS development by inhibiting ovarian androgen production. Consistently in a small pilot study, dihydroartemisinin effectively reduced androgen levels, reduced immature follicles, and improved the estrous cycle in PCOS patients who strictly met all the three Rotterdam Criteria, namely hyperandrogenism, ovulation dysfunction, and polycystic ovaries on ultrasound. Nevertheless, clinical diagnosis of PCOS can be established as long as a patient fulfill two of the three Rotterdam Criteria. The present study aims to explore the therapeutic effects of dihydroartemisinin in patients with PCOS who met at least two of three (≥2) Rotterdam Criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
dihydroartemisinin 40mg tid po for 90 consecutive days
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Recovery of regular menses
Record of vaginal bleeding within 6 months after start taking dihydroartemisinin
Time frame: 180 days
Serum anti-Mullerian hormone (AMH)
Serum AMH before and after 90 days of medication
Time frame: 90 days
Free androgen index (FAI)
FAI (Total testosterone in nmol/L / SHBG in nmol/L X 100) before and after 90 days of medication
Time frame: 90 days
Number of immature follicles
Total number of immature follicles measuring 2-9 mm in diameter on ultrasound before and after 90 days of medication
Time frame: 90 days
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