Polycystic Ovary Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
dihydroartemisinin 40mg tid po for 90 consecutive days
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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: 1. Irregular cycles and ovulatory dysfunction: \< 21 or \> 35 days or \< 8 cycles per year; \> 90 days for any one cycle 2. Polycystic ovaries: ≥12 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound. 3. Elevated androgen levels: total testosterone\>1.67 nmol/L.
Exclusion criteria
* Pregnancy. * Patients with other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc. * Patients with other serious diseases affecting heart, liver, kidney, or other major organs. * Patients with any type of cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of regular menses | 180 days | Record of vaginal bleeding within 6 months after start taking dihydroartemisinin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum anti-Mullerian hormone (AMH) | 90 days | Serum AMH before and after 90 days of medication |
| Free androgen index (FAI) | 90 days | FAI (Total testosterone in nmol/L / SHBG in nmol/L X 100) before and after 90 days of medication |
| Number of immature follicles | 90 days | Total number of immature follicles measuring 2-9 mm in diameter on ultrasound before and after 90 days of medication |
Countries
China
Outcome results
None listed