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Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670304
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University

Tracking Information
First Submitted Date  ICMJE August 7, 2013
First Posted Date  ICMJE February 1, 2016
Last Update Posted Date February 1, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
incidence of early OHSS [ Time Frame: up to 1 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
  • vascular endothelial growth factor level [ Time Frame: up to 1 months ]
    vascular endothelial growth factor in pg/ml
  • incidence of hydrothorax [ Time Frame: up to 1 months ]
  • incidence of liver dysfunction [ Time Frame: up to 1 months ]
  • incidence of renal dysfunction [ Time Frame: up to 1 months ]
  • incidence of electrolytic imbalance [ Time Frame: up to 1 months ]
  • incidence of hemoconcentration [ Time Frame: up to 1 months ]
  • incidence of elevated WBC [ Time Frame: up to 1 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS
Official Title  ICMJE The Randomized Controlled Trial Study of Letrozole in the Prevention of Medium and Severe Ovarian Hyperstimulation Syndrome in Invitro Fertilization Treatment
Brief Summary Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as one candidate for the treatment or prevention of ovarian hyperstimulation syndrome.
Detailed Description Letrozole was proved to be effective in decreasing the estradiol level of luteal phase after ovum picked up. In this randomized controlled study, investigators try to observe the effectiveness of letrozole on decreasing the incidence of early ovarian hyperstimulation syndrome and vascular epithelium growth factor level of women with high ovarian hyperstimulation syndrome risks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Ovarian Hyperstimulation Syndrome
Intervention  ICMJE
  • Drug: letrozole
    letrozole from the day of oocyte retrieval for 5 days
    Other Name: Femara
  • Drug: Aspirin
    aspirin from the day of oocyte retrieval for 5 days
Study Arms  ICMJE
  • Experimental: letrozole
    letrozole for the first day after ovum picked up at least for 5 days.
    Intervention: Drug: letrozole
  • Active Comparator: aspirin
    asprin for the first day after ovum picked up at least for 5 days.
    Intervention: Drug: Aspirin
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2016)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • infertile women undergoing IVF treatment with more than 25 oocytes collected.

Exclusion Criteria:

  • letrozole contraindications,e.g. severe hepatic and renal dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02670304
Other Study ID Numbers  ICMJE 28843020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: no plan to make IPD available
Responsible Party Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE First Affiliated Hospital, Sun Yat-Sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account First Affiliated Hospital, Sun Yat-Sen University
Verification Date January 2016

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