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

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ClinicalTrials.gov Identifier: NCT01431352
Recruitment Status : Unknown
Verified November 2013 by Xiaoke Wu, Heilongjiang University of Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : September 9, 2011
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine

Tracking Information
First Submitted Date  ICMJE September 6, 2011
First Posted Date  ICMJE September 9, 2011
Last Update Posted Date November 5, 2013
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2011)
Live birth rate [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01431352 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2013)
  • 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 ]
    Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.
  • Change in metabolic profile [ Time Frame: Up to 1 year ]
    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 ]
    weight, vital signs, and hip and waist measurements.
  • Pregnancy complications [ Time Frame: Up to 1 year ]
    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 ]
  • Safety parameters [ Time Frame: Up to 1 year ]
    renal and liver function tests and complete blood count.
  • Side effect profile [ Time Frame: Up to 1 year ]
    The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2011)
  • Pregnancy rate [ Time Frame: Up to 1 year ]
  • Ovulation rate [ Time Frame: Up to 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
Official Title  ICMJE The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Letrozole+ Chinese herbal medicine granules
    Interventions:
    • Drug: Letrozole
    • Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo
  • Placebo Comparator: Letrozole+ Chinese herbal medicine granules placebo
    Intervention: Drug: Letrozole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 4, 2013)
420
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2011)
180
Estimated Study Completion Date  ICMJE August 2014
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01431352
Other Study ID Numbers  ICMJE Letrozole
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiaoke Wu, Heilongjiang University of Chinese Medicine
Study Sponsor  ICMJE Heilongjiang University of Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Heilongjiang University of Chinese Medicine
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP