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Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS

Primary Purpose

Ovarian Hyperstimulation Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
letrozole
Aspirin
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome focused on measuring letrozole, ovarian hyperstimulating syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • letrozole contraindications,e.g. severe hepatic and renal dysfunction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    letrozole

    aspirin

    Arm Description

    letrozole for the first day after ovum picked up at least for 5 days.

    asprin for the first day after ovum picked up at least for 5 days.

    Outcomes

    Primary Outcome Measures

    incidence of early OHSS

    Secondary Outcome Measures

    vascular endothelial growth factor level
    vascular endothelial growth factor in pg/ml
    incidence of hydrothorax
    incidence of liver dysfunction
    incidence of renal dysfunction
    incidence of electrolytic imbalance
    incidence of hemoconcentration
    incidence of elevated WBC

    Full Information

    First Posted
    August 7, 2013
    Last Updated
    January 28, 2016
    Sponsor
    First Affiliated Hospital, Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02670304
    Brief Title
    Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS
    Official Title
    The Randomized Controlled Trial Study of Letrozole in the Prevention of Medium and Severe Ovarian Hyperstimulation Syndrome in Invitro Fertilization Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    August 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital, Sun Yat-Sen University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Hyperstimulation Syndrome
    Keywords
    letrozole, ovarian hyperstimulating syndrome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    letrozole
    Arm Type
    Experimental
    Arm Description
    letrozole for the first day after ovum picked up at least for 5 days.
    Arm Title
    aspirin
    Arm Type
    Active Comparator
    Arm Description
    asprin for the first day after ovum picked up at least for 5 days.
    Intervention Type
    Drug
    Intervention Name(s)
    letrozole
    Other Intervention Name(s)
    Femara
    Intervention Description
    letrozole from the day of oocyte retrieval for 5 days
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin
    Intervention Description
    aspirin from the day of oocyte retrieval for 5 days
    Primary Outcome Measure Information:
    Title
    incidence of early OHSS
    Time Frame
    up to 1 months
    Secondary Outcome Measure Information:
    Title
    vascular endothelial growth factor level
    Description
    vascular endothelial growth factor in pg/ml
    Time Frame
    up to 1 months
    Title
    incidence of hydrothorax
    Time Frame
    up to 1 months
    Title
    incidence of liver dysfunction
    Time Frame
    up to 1 months
    Title
    incidence of renal dysfunction
    Time Frame
    up to 1 months
    Title
    incidence of electrolytic imbalance
    Time Frame
    up to 1 months
    Title
    incidence of hemoconcentration
    Time Frame
    up to 1 months
    Title
    incidence of elevated WBC
    Time Frame
    up to 1 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: infertile women undergoing IVF treatment with more than 25 oocytes collected. Exclusion Criteria: letrozole contraindications,e.g. severe hepatic and renal dysfunction

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no plan to make IPD available

    Learn more about this trial

    Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS

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