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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Hyperstimulation Syndrome
• Intervention / Treatment: Drug: letrozole; Drug: Aspirin

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: letrozole; letrozole for the first day after ovum picked up at least for 5 days.	Drug: letrozole; letrozole from the day of oocyte retrieval for 5 days; Other Names: Femara
Active Comparator: aspirin; asprin for the first day after ovum picked up at least for 5 days.	Drug: Aspirin; aspirin from the day of oocyte retrieval for 5 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
incidence of liver dysfunction		up to 1 months
incidence of renal dysfunction		up to 1 months
incidence of electrolytic imbalance		up to 1 months
incidence of hemoconcentration		up to 1 months
incidence of elevated WBC		up to 1 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: letrozole; ovarian hyperstimulating syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Disease; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Syndrome; Ovarian Hyperstimulation Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Aspirin; Letrozole
• Other Study ID Numbers: 28843020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no plan to make IPD available