Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Heilongjiang University of Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01431352
First received: September 6, 2011
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Drug: Letrozole
Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Heilongjiang University of Chinese Medicine:

Primary Outcome Measures:
  • Live birth rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ovulation rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Miscarriage rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Change in hormonal profile [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.

  • Change in metabolic profile [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    glucose and insulin concentrations, cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.

  • Change in physical measurements [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    weight, vital signs, and hip and waist measurements.

  • Pregnancy complications [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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.

  • Birth defects [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    renal and liver function tests and complete blood count.

  • Side effect profile [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.


Estimated Enrollment: 420
Study Start Date: September 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole+ Chinese herbal medicine granules 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.
Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo
twice a day for 6 month
Placebo Comparator: Letrozole+ Chinese herbal medicine granules placebo 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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. 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.
  2. History of at least one year of infertility.
  3. Age between 20 and 40 years old.
  4. 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.
  5. Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.

Exclusion criteria

  1. History of significant system diseases such as heart, lung, or kidney diseases.
  2. History of other endocrine disorders.
  3. Use of hormonal therapy, including metformin, in the past 3 months.
  4. Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431352

Contacts
Contact: Lihui Hou, MD 86-451-82130094 houlihui2007@hotmail.com
Contact: Xiaoke Wu, MD. PhD 86-451-82130094 xiaokewu2002@vip.sina.com

Locations
China, Anhui
Affiliated Hospital of Anhui University of Chinese Medicine Active, not recruiting
Hefei, Anhui, China
China, Guangdong
Guangzhou Medical School First Affiliated Hospital Active, not recruiting
Guangzhou, Guangdong, China
China, Heilongjiang
Daqing Oilfield General Hospital Active, not recruiting
Daqing, Heilongjiang, China
Daqing Longnan hospital Active, not recruiting
Daqing, Heilongjiang, China
First Affliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Muer An, MD         
Principal Investigator: Muer An, MD         
Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine Recruiting
Herbin, Heilongjiang, China, 150040
Contact: Lihui Hou , MD.    86-451-82130094      
Principal Investigator: Lihui Hou, MD.         
Mudanjiang maternal and children hospital Active, not recruiting
Mudanjiang, Heilongjiang, China
China, Henan
2nd Affiliated Hospital of Henan University of Chinese Medicine Active, not recruiting
Zhengzhou, Henan, China
China, Hunan
First Affiliated Hospital of Hunan University of Chinese Active, not recruiting
Changsha, Hunan, China
China, Jiangsu
SuqianMaternal and Child Health Hospital Active, not recruiting
Suqian, Jiangsu, China
Maternal and Child Health Hospital of Xuzhou Active, not recruiting
Xuzhou, Jiangsu, China
China, Jiangxi
First Hospital, Jiangxi college of Chinese Medicine Active, not recruiting
Nanchang, Jiangxi, China
China, Liaoning
Dalian Maternal and Child Health Hospital Recruiting
Dalian, Liaoning, China
Principal Investigator: Xiaoguang Shao, MD         
China, Shanxi
Shanxi Hospital of Chinese Medicine Active, not recruiting
Taiyuan, Shanxi, China
China, Tianjin
Second Affiliated Hospital, Tianjin University of Chinese Medicine Active, not recruiting
Tianjin, Tianjin, China
First Affiliated Hospital of Tianjin University of Chinese Medicine Active, not recruiting
Tianjin, Tianjin, China
China, Zhejiang
Zhejiang province hospital of integrated traditional and western medicine Recruiting
Hangzhou, Zhejiang, China
Contact: Xin Sun, MD         
Principal Investigator: Xin Sun, MD         
China
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine Active, not recruiting
Harbin, China
Sponsors and Collaborators
Heilongjiang University of Chinese Medicine
  More Information

No publications provided

Responsible Party: Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT01431352     History of Changes
Other Study ID Numbers: Letrozole
Study First Received: September 6, 2011
Last Updated: November 4, 2013
Health Authority: China: Ministry of Science and Technology

Keywords provided by Heilongjiang University of Chinese Medicine:
Polycystic ovary syndrome
Randomized controlled trial
Chinese herbal medicine
Chinese herbal medicine granules
Letrozole
Live birth

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014