Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS

Ovarian Hyperstimulation Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670304
• Other study ID #: 28843020
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2013
• Last updated: January 28, 2016
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Syndrome

Intervention

Drug:
• letrozole
letrozole from the day of oocyte retrieval for 5 days
• Aspirin
aspirin from the day of oocyte retrieval for 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of early OHSS		up to 1 months
Secondary	vascular endothelial growth factor level	vascular endothelial growth factor in pg/ml	up to 1 months
Secondary	incidence of hydrothorax		up to 1 months
Secondary	incidence of liver dysfunction		up to 1 months
Secondary	incidence of renal dysfunction		up to 1 months
Secondary	incidence of electrolytic imbalance		up to 1 months
Secondary	incidence of hemoconcentration		up to 1 months
Secondary	incidence of elevated WBC		up to 1 months