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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dihydroartemisinin Treatment Arm | Experimental | The subjects take dihydroartemisinin, 40mg tid for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dihydroartemisinin | Drug | dihydroartemisinin 40mg tid po for 90 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of regular menses | Record of vaginal bleeding within 6 months after start taking dihydroartemisinin | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum anti-Mullerian hormone (AMH) | Serum AMH before and after 90 days of medication | 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 |
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Inclusion Criteria:
BMI 18.5-28kg/M2
No plan for pregnancy in the coming 6 months
Patients should meet two of the three following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoying Li, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| C039060 | artenimol |
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| 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 | 90 days |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |