Clinical trial · Interventional
Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine
Letrozole and Berberine in Infertile PCOS Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Berberine | Drug | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
| Letrozole -Berberine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Letrozole -Berberine
- interventionNames
- Drug: Letrozole -Berberine
- type
- ACTIVE_COMPARATOR
- label
- Letrozole
- interventionNames
- Drug: Letrozole
- type
- ACTIVE_COMPARATOR
- label
- Berberine
- interventionNames
- Drug: Berberine
Primary outcomes (1)
- measure
- Live-birth rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Chinese women * Age between 20 and 40 years. * Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3): 1. Oligo- or anovulation 2. Clinical and/or biochemical signs of hyperandrogenism 3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome) * 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: * Use of hormonal drugs or other medications including Chinese herbal prescriptions in the past 3 months. * Patients with known sever organ dysfunction or mental illness. * Pregnancy, post-abortion or postpartum within the past 6 weeks. * Breastfeeding within the last 6 months. * Not willing to give written consent to the study.
References
Publications (2)
- DERIVEDZhou 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. PMID 34085287
- DERIVEDLi 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. PMID 24282248