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Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS

NCT ID: NCT02670304

Last Updated: 2016-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Hyperstimulation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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letrozole

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

Group Type EXPERIMENTAL

letrozole

Intervention Type DRUG

letrozole from the day of oocyte retrieval for 5 days

aspirin

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

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

aspirin from the day of oocyte retrieval for 5 days

Interventions

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letrozole

letrozole from the day of oocyte retrieval for 5 days

Intervention Type DRUG

Aspirin

aspirin from the day of oocyte retrieval for 5 days

Intervention Type DRUG

Other Intervention Names

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Femara

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* letrozole contraindications,e.g. severe hepatic and renal dysfunction
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhou Canquan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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28843020

Identifier Type: -

Identifier Source: org_study_id

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