NCT02670304

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

August 7, 2013

Last Update Submit

January 28, 2016

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

letrozoleovarian hyperstimulating syndrome

Outcome Measures

Primary Outcomes (1)

  • incidence of early OHSS

    up to 1 months

Secondary Outcomes (7)

  • vascular endothelial growth factor level

    up to 1 months

  • incidence of hydrothorax

    up to 1 months

  • incidence of liver dysfunction

    up to 1 months

  • incidence of renal dysfunction

    up to 1 months

  • incidence of electrolytic imbalance

    up to 1 months

  • +2 more secondary outcomes

Study Arms (2)

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

letrozoleDRUG

letrozole from the day of oocyte retrieval for 5 days

Also known as: Femara
letrozole
AspirinDRUG

aspirin from the day of oocyte retrieval for 5 days

aspirin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

LetrozoleAspirin

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2013

First Posted

February 1, 2016

Study Start

January 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

February 1, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

no plan to make IPD available