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Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS

The Randomized Controlled Trial Study of Letrozole in the Prevention of Medium and Severe Ovarian Hyperstimulation Syndrome in Invitro Fertilization Treatment

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02670304
Enrollment
100
Registered
2016-02-01
Start date
2012-01-31
Completion date
2013-08-31
Last updated
2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

letrozole, ovarian hyperstimulating syndrome

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.

Interventions

DRUGletrozole

letrozole from the day of oocyte retrieval for 5 days

DRUGAspirin

aspirin from the day of oocyte retrieval for 5 days

Sponsors

First Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
incidence of early OHSSup to 1 months

Secondary

MeasureTime frameDescription
incidence of hydrothoraxup to 1 months
incidence of liver dysfunctionup to 1 months
incidence of renal dysfunctionup to 1 months
vascular endothelial growth factor levelup to 1 monthsvascular endothelial growth factor in pg/ml
incidence of hemoconcentrationup to 1 months
incidence of elevated WBCup to 1 months
incidence of electrolytic imbalanceup to 1 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026