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Letrozole, berberine, or their combination for anovulatory infertility in women with polycystic ovary syndrome: study design of a double blind randomised controlled trial

Letrozole, berberine, or their combination for anovulatory infertility in women with polycystic ovary syndrome: study design of a double blind randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000376
Enrollment
Unknown
Registered
2009-10-07
Start date
2009-12-02
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovarian syndrome

Interventions

Berberine Group:Berberine and Letrozole Placebo
Letrozole Group:Letrozole and Berberine Placebo
Berberine and Letrozole Group:Berberine and Letrozole

Sponsors

Affiliated Hospital Heilongjiang University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Age between 20 and 40 years; 2. Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 of 3): (1) Oligo-ovulation or anovulation; (2) Clinical and/or biochemical signs of hyperandrogenism; (3) PCOs and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumours and Cushing's syndrome). 3. At least one patent tube and normal uterine cavity shown by hysterosalpingogram, hysterosalpingo-contrast sonography or diagnostic laparoscopy within 3 years; 4. Sperm concentration 15*10^6/mL and progressive motility (grades a* and b**) >=40%. *Grade a: rapid progressive motility (sperm moving swiftly, usually in a straight line). **Grade b: slow or sluggish progressive motility (sperm may be less linear in their progression); 5. History of 1 year of infertility.

Exclusion criteria

Exclusion criteria: 1. Patients with known severe organ dysfunction or mental illness; 2. Use of hormonal drugs or other medications including Chinese herbal prescriptions in the past 3 months; 3. Pregnancy, postabortion or postpartum within the past 6 weeks; 4. Breastfeeding within the past 6 months; 5. Not willing to give written consent for the study.

Design outcomes

Secondary

MeasureTime frame
Ovulation rate;Ongoing pregnancy rate;Multiple pregnancy rates;Miscarriage rate;Other pregnancy complications;Follicle-stimulating hormone (FSH);Luteinising hormone (LH);Total testosterone (T);sex hormone-binding globulin;Fasting glucose;Fasting insulin concentrations;cholesterol;triglycerides;high-density lipoprotein cholesterol (HDL-C);low-density lipoprotein cholesterol (LDL-C);

Primary

MeasureTime frame
live birth Rate;

Countries

China

Contacts

Public ContactWu Xiaoke
xiaokewu2002@vip.sina.com+86 13796025599

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 13, 2026