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
About this trial
This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome focused on measuring letrozole, ovarian hyperstimulating syndrome
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
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
NCT ID
NCT02670304
First Posted
August 7, 2013
Last Updated
January 28, 2016
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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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