Preventive Application of Letrozole Decrease Incidence of... | NCT02670304

Studies
Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS

NCT02670304

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Completed

Last Update Posted

Feb 1, 2016Estimated

Enrollment

100Actual

Phase

Phase 4

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

letrozole
Aspirin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jul 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Aug 7, 2013

First Submission Date that Met QC Criteria

Jan 28, 2016

First Posted Date

Feb 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2016

Last Update Posted Date

Feb 1, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhou Canquan, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
letrozole	Experimental	letrozole for the first day after ovum picked up at least for 5 days.	Drug: letrozole
aspirin	Active Comparator	asprin for the first day after ovum picked up at least for 5 days.	Drug: Aspirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
letrozole	Drug	letrozole from the day of oocyte retrieval for 5 days	letrozole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of early OHSS		up to 1 months

Secondary Outcomes

Measure	Description	Time Frame
vascular endothelial growth factor level	vascular endothelial growth factor in pg/ml	up to 1 months
incidence of hydrothorax		up to 1 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

no plan to make IPD available

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Mar 21, 2016
Reset	Apr 19, 2016
Release	Dec 6, 2016
Reset	Jan 31, 2017

Submission Tracking

Estimated Results First Submitted Date

Mar 21, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 21, 2016			Apr 19, 2016
Dec 6, 2016

Condition Browse Module

MeSH Terms

ID	Term
D016471	Ovarian Hyperstimulation Syndrome

Ancestor Terms

ID	Term
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077289	Letrozole
D001241	Aspirin

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided