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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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Polycystic ovary syndrome (PCOS) is a heterogeneous disorder affecting almost4%-7% of the female population of reproductive age. Its heterogeneity is characterized by a wide spectrum of features, including ovulatory dysfunction and infertility, hyperandrogenism, hyperinsulinemia, insulin resistance (IR), and progression to type 2 diabetes.Since the Ming Dynasty in China,PCOS has been defined as "phlegm and wetness"infertility in traditional Chinese medicine ,namely "metabolic infertility".Chinese herbs have been used to treat PCOS for thousands of years with good effects.Berberine has also been used for diabetic patients in traditional Chinese medicine for hundreds of years. Recent studies have reported its effects on hyperglycemia and dyslipidemia.The purpose of this study is to determine whether Letrozole combined with berberine are effective in the treatment of infertile PCOS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole -Berberine | Experimental |
| |
| Letrozole | Active Comparator |
| |
| Berberine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole -Berberine | Drug | Letrozole 2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6. Berberine 1.5g daily for 6 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Live-birth rate | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ovulation rate | Up to 1 year | |
| Ongoing pregnancy rate at around gestation 8-10 weeks | Up to 1 year | |
| Multiple pregnancy rate |
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Inclusion Criteria:
Chinese women
Age between 20 and 40 years.
Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3):
At least one patent tube and normal uterine cavity shown by hysterosalpingogram, HyCoSi or diagnostic laparoscopy within three years.
Sperm concentration 20×106/mL and progressive motility (grades a and b) ≥50%.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Li, MD.PhD. | Contact | liyantcm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lihui Hou, MD. | The First Affliated Hospital,Heilongjiang University of Chinese Medicine . | Study Chair |
| Xiaoke Wu, MD.PhD. | The First Affliated Hospital,Heilongjiang University of Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Anhui University of Chinese Medicine | Active, not recruiting | Hefei | Anhui | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34085287 | Derived | Zhou K, Zhang J, Xu L, Lim CED. Chinese herbal medicine for subfertile women with polycystic ovarian syndrome. Cochrane Database Syst Rev. 2021 Jun 4;6(6):CD007535. doi: 10.1002/14651858.CD007535.pub4. | |
| 24282248 | Derived | Li Y, Kuang H, Shen W, Ma H, Zhang Y, Stener-Victorin E, Hung E, Ng Y, Liu J, Kuang H, Hou L, Wu X. Letrozole, berberine, or their combination for anovulatory infertility in women with polycystic ovary syndrome: study design of a double-blind randomised controlled trial. BMJ Open. 2013 Nov 25;3(11):e003934. doi: 10.1136/bmjopen-2013-003934. |
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| Letrozole | Drug | Letrozole 2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6. Berberine Placebo 5 tablet tds for 6 months |
|
| Berberine | Drug | Berberine 1.5g daily for 6 month. Letrozole placebo 1 tablet daily from day 5 of the menses for 5 days for month 1 to 3, 2 tablets daily from day 5 of the menses for 5 days for month 4 to 6. |
|
| Up to 1 year. |
| Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation | Up to 1 year |
| Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies. | Up to 1 year |
| Infant outcome | Up to 1 year |
| Changes in metabolic profile: glucose and insulin concentrations, cholesterol, triglycerides, high density lipoprotein (HDL-C) and low density lipoprotein (LDL-C) | Up to 1 year |
| Changes in hormonal profile: Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), total testosterone (T), Sex hormone-binding globulin (SHBG) and Dehydroepiandrosterone sulfate (DHEAS) | Up to 1 year |
| Side effect. | Up to 1 year |
| Affiliated Hospital of Guangzhou Medical University |
| Active, not recruiting |
| Guangzhou |
| Guangdong |
| China |
| Guangzhou Medical School First Affiliated Hospital | Recruiting | Guangzhou | Guangdong | China |
|
| Daqing LongNa Hospital | Active, not recruiting | Daqing | Heilongjiang | 163000 | China |
| Daqing Longnan hospital | Active, not recruiting | Daqing | Heilongjiang | China |
| Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine | Recruiting | Harbin | Heilongjiang | 150040 | China |
|
| First Affliated Hospital of Harbin Medical University | Active, not recruiting | Harbin | Heilongjiang | China |
| Mudanjiang maternal and children hospital | Active, not recruiting | Mudanjiang | Heilongjiang | China |
| 2nd Affiliated Hospital of Henan University of Chinese Medicine | Active, not recruiting | Zhengzhou | Henan | China |
| First Affiliated Hospital of Hunan University of Chinese | Active, not recruiting | Changsha | Hunan | China |
| SuqianMaternal and Child Health Hospital | Active, not recruiting | Suqian | Jiangsu | China |
| First Hospital, Jiangxi college of Chinese Medicine | Active, not recruiting | Nanchang | Jiangxi | China |
| Dalian Maternal and Child Health Hospital | Active, not recruiting | Dalian | Liaoning | China |
| Shanxi Hospital of Chinese Medicine | Active, not recruiting | Taiyuan | Shanxi | China |
| First Affiliated Hospital of Tianjin University of Chinese Medicine | Active, not recruiting | Tianjin | Tianjin Municipality | China |
| Second Affiliated Hospital, Tianjin University of Chinese Medicine | Active, not recruiting | Tianjin | Tianjin Municipality | China |
| Zhejiang province hospital of integrated traditional and western medicine | Active, not recruiting | Hangzhou | Zhejiang | China |
| Second Affiliated Hospital of Heilongjiang University of Chinese Medicine | Active, not recruiting | Harbin | China |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | 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 |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D001599 | Berberine |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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