Polycystic Ovary SyndromeNCT01431352
Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
A study testing Letrozole in people with Polycystic Ovary Syndrome, run by Heilongjiang University of Chinese Medicine at 18 sites in China.
Trial summary
This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating site. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 18 sitesChina
- Study dates
- Sep 2009to Aug 2014
- 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 with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days.
- History of at least one year of infertility.
- Age between 20 and 40 years old.
- Normal semen analysis based on World Health Organization criteria (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration ≥15 × 106/mL and total motility ≥40% in the semen analysis of the husband was required for the woman to be included.
- Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.
Who cannot join
- History of significant system diseases such as heart, lung, or kidney diseases.
- History of other endocrine disorders.
- Use of hormonal therapy, including metformin, in the past 3 months.
- Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites, 4 recruiting
- Active, not recruiting
First Affiliated Hospital of Hunan University of Chinese
Changsha, Hunan
- Recruiting
Dalian Maternal and Child Health Hospital
Dalian, Liaoning
Xiaoguang Shao, MD
- Active, not recruiting
Daqing Longnan hospital
Daqing, Heilongjiang
- Active, not recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang
- Active, not recruiting
Guangzhou Medical School First Affiliated Hospital
Guangzhou, Guangdong
- Recruiting
Zhejiang province hospital of integrated traditional and western medicine
Hangzhou, Zhejiang
Xin Sun, MD
Xin Sun, MD
- Recruiting
First Affliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Muer An, MD
Muer An, MD
- 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
- Recruiting
Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine
Herbin, Heilongjiang, 150040
Lihui Hou, MD., 86-451-82130094
Lihui Hou, MD.
- 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
Maternal and Child Health Hospital of Xuzhou
Xuzhou, Jiangsu
- Active, not recruiting
2nd Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan
About this study
Official title: The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial
This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating site. Participants will be randomized into one of the two treatment arms: letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of the present study is to determine the efficacy of combined treatment with letrozole and CHMG on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that the combination of letrozole and CHMG is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in PCOS women than letrozole alone.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Letrozole, Chinese herbal medicine granules or Chinese herbal medicine granules placebo
- Keywords
- Polycystic ovary syndrome, Randomized controlled trial, Chinese herbal medicine, Chinese herbal medicine granules, Letrozole, Live birth
- 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.
LetrozoleDrug
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.
Chinese herbal medicine granules or Chinese herbal medicine granules placeboDrug
twice a day for 6 month
| Study group | Role | What they receive |
|---|---|---|
| Letrozole+ Chinese herbal medicine granules | Experimental | Not described Receives: Drug: Letrozole; Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo |
| Letrozole+ Chinese herbal medicine granules placebo | Placebo comparator | Not described Receives: Drug: Letrozole |
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
Miscarriage rate
Measured: Up to 1 year
Change in hormonal profile
Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.
Measured: Up to 1 year
Change in metabolic profile
glucose and insulin concentrations, cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.
Measured: Up to 1 year
Change in physical measurements
weight, vital signs, and hip and waist measurements.
Measured: Up to 1 year
Pregnancy complications
gestational diabetes, pregnancy-induced hypertension, intrauterine growth retardation, ectopic pregnancy, congenital anomaly, preeclampsia, preterm labor, HELLP syndrome, preterm premature rupture of membranes, placental abruption, placenta accreta, placenta previa, postpartum hemorrhage, and others.
Measured: Up to 1 year
Birth defects
Measured: Up to 1 year
Safety parameters
renal and liver function tests and complete blood count.
Measured: Up to 1 year
Side effect profile
The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.
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 posted9 Sep 2011 (estimated)
- Study startSep 2009
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoke Wu, Heilongjiang University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431352
- Sponsor's protocol ID
- Letrozole
- Status last verified
- Nov 2013
- First submitted
- 6 Sep 2011
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01431352
- Acronym / sponsor ID
- Letrozole
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic ovary syndrome, Randomized controlled trial, Chinese herbal medicine, Chinese herbal medicine granules, Letrozole, Live birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 9 Sep 2011 (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.
This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating site. Participants will be randomized into one of the two treatment arms: letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of the present study is to determine the efficacy of combined treatment with letrozole and CHMG on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that the combination of letrozole and CHMG is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in PCOS women than letrozole alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole+ Chinese herbal medicine granules | Experimental | Drug: Letrozole, Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo |
| Letrozole+ Chinese herbal medicine granules placebo | Placebo comparator | Drug: Letrozole |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese women with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days.
- History of at least one year of infertility.
- Age between 20 and 40 years old.
- Normal semen analysis based on World Health Organization criteria (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration ≥15 × 106/mL and total motility ≥40% in the semen analysis of the husband was required for the woman to be included.
- Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.
Key exclusion criteria (4 listed)
- History of significant system diseases such as heart, lung, or kidney diseases.
- History of other endocrine disorders.
- Use of hormonal therapy, including metformin, in the past 3 months.
- Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.
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 |
|---|---|---|
| Letrozole2.5 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. | Drug | Letrozole+ Chinese herbal medicine granules, Letrozole+ Chinese herbal medicine granules placebo |
| Chinese herbal medicine granules or Chinese herbal medicine granules placebotwice a day for 6 month | Drug | Letrozole+ Chinese herbal medicine granules |
Primary outcome
Live birth rate
Time frame: Up to 2 years
9 secondary outcomes
Ovulation rate
Time frame: Up to 1 year
Miscarriage rate
Time frame: Up to 1 year
Change in hormonal profile
Time frame: Up to 1 year
Change in metabolic profile
Time frame: Up to 1 year
Change in physical measurements
Time frame: Up to 1 year
Pregnancy complications
Time frame: Up to 1 year
Birth defects
Time frame: Up to 1 year
Safety parameters
Time frame: Up to 1 year
Side effect profile
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 5 Nov 2013.
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
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 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 5 inclusion and 4 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 5 Nov 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. Some participants in this study may receive a placebo. 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 Lihui Hou, MD (86-451-82130094, houlihui2007@hotmail.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?
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 5 Nov 2013.