Polycystic Ovary SyndromeNCT01116167
Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine
A study testing Letrozole -Berberine, Letrozole and Berberine in people with Polycystic Ovary Syndrome, run by Heilongjiang University of Chinese Medicine at 18 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Letrozole -Berberine, Letrozole and Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 18 sitesChina
- Study dates
- Oct 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Chinese women
- Age between 20 and 40 years.
- Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3):
- Oligo- or anovulation
- Clinical and/or biochemical signs of hyperandrogenism
- 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%.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
Yan Li, MD.PhD. contact
18 sites in 1 country
China18 sites, 2 recruiting
- Active, not recruiting
First Affiliated Hospital of Hunan University of Chinese
Changsha, Hunan
- Active, not recruiting
Dalian Maternal and Child Health Hospital
Dalian, Liaoning
- Active, not recruiting
Daqing LongNa Hospital
Daqing, Heilongjiang, 163000
- Active, not recruiting
Daqing Longnan hospital
Daqing, Heilongjiang
- Active, not recruiting
Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
- Recruiting
Guangzhou Medical School First Affiliated Hospital
Guangzhou, Guangdong
Hongxia Ma, MD
- Active, not recruiting
Zhejiang province hospital of integrated traditional and western medicine
Hangzhou, Zhejiang
- Recruiting
Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040
Xiaoke Wu, MD.PhD., 86-451-8213 0094, xiaokewu2002@vip.sina.com
Lihui Hou, MD., 86-451-8213 0094, houlihui2007@sina.com
- Active, not recruiting
First Affliated Hospital of Harbin Medical University
Harbin, Heilongjiang
- Active, not recruiting
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin
- Active, not recruiting
Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui
- Active, not recruiting
Mudanjiang maternal and children hospital
Mudanjiang, Heilongjiang
- Active, not recruiting
First Hospital, Jiangxi college of Chinese Medicine
Nanchang, Jiangxi
- Active, not recruiting
SuqianMaternal and Child Health Hospital
Suqian, Jiangsu
- Active, not recruiting
Shanxi Hospital of Chinese Medicine
Taiyuan, Shanxi
- Active, not recruiting
First Affiliated Hospital of Tianjin University of Chinese Medicine
Tianjin, Tianjin Municipality
- Active, not recruiting
Second Affiliated Hospital, Tianjin University of Chinese Medicine
Tianjin, Tianjin Municipality
- Active, not recruiting
2nd Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan
About this study
Official title: Letrozole and Berberine in Infertile PCOS Patients
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
- Polycystic Ovary Syndrome
- Being tested
- Letrozole -Berberine, Letrozole, Berberine
- Keywords
- Polycystic Ovary Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole -BerberineDrug
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.
LetrozoleDrug
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
BerberineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Letrozole -Berberine | Experimental | Not described Receives: Drug: Letrozole -Berberine |
| Letrozole | Active comparator | Not described Receives: Drug: Letrozole |
| Berberine | Active comparator | Not described Receives: Drug: Berberine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live-birth rate
Measured: Up to 2 years
Secondary outcomes (9)
Ovulation rate
Measured: Up to 1 year
Ongoing pregnancy rate at around gestation 8-10 weeks
Measured: Up to 1 year
Multiple pregnancy rate
Measured: Up to 1 year.
Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation
Measured: 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.
Measured: Up to 1 year
Infant outcome
Measured: 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)
Measured: 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)
Measured: Up to 1 year
Side effect.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Principal investigator, Xiaoke Wu, Heilongjiang University of Chinese Medicine
- Investigators
- Lihui Hou, MD., Study chair, The First Affliated Hospital,Heilongjiang University of Chinese Medicine .Xiaoke Wu, MD.PhD., Study chair, The First Affliated Hospital,Heilongjiang University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116167
- Sponsor's protocol ID
- you070316
- Status last verified
- May 2013
- First submitted
- 27 Apr 2010
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34085287Li 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.
PubMed 24282248
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole and Berberine in Infertile PCOS Patients
- ClinicalTrials.gov ID
- NCT01116167
- Acronym / sponsor ID
- you070316
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Oct 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Letrozole -Berberine | Experimental | Drug: Letrozole -Berberine |
| Letrozole | Active comparator | Drug: Letrozole |
| Berberine | Active comparator | Drug: Berberine |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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%.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole -BerberineLetrozole 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. | Drug | Letrozole -Berberine |
| LetrozoleLetrozole 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 | Drug | Letrozole |
| BerberineBerberine 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. | Drug | Berberine |
Primary outcome
Live-birth rate
Time frame: Up to 2 years
9 secondary outcomes
Ovulation rate
Time frame: Up to 1 year
Ongoing pregnancy rate at around gestation 8-10 weeks
Time frame: Up to 1 year
Multiple pregnancy rate
Time frame: Up to 1 year.
Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation
Time frame: 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.
Time frame: Up to 1 year
Infant outcome
Time frame: 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)
Time frame: 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)
Time frame: Up to 1 year
Side effect.
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
- Derived from this study: PubMed 34085287Zhou 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.
- Derived from this study: PubMed 24282248Li 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Li, MD.PhD. contact
Lihui Hou, MD. study chair
The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Xiaoke Wu, MD.PhD. study chair
The First Affliated Hospital,Heilongjiang University of Chinese Medicine
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole -Berberine, Letrozole and Berberine in people with Polycystic Ovary Syndrome, run by Heilongjiang University of Chinese Medicine at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Li, MD.PhD. (liyantcm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live-birth rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01116167, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2013.