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Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02670304
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Information provided by (Responsible Party):
Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Ovarian Hyperstimulation Syndrome Drug: letrozole Drug: Aspirin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Randomized Controlled Trial Study of Letrozole in the Prevention of Medium and Severe Ovarian Hyperstimulation Syndrome in Invitro Fertilization Treatment
Study Start Date : January 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

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 Name: 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

Primary Outcome Measures :
  1. incidence of early OHSS [ Time Frame: up to 1 months ]

Secondary Outcome Measures :
  1. vascular endothelial growth factor level [ Time Frame: up to 1 months ]
    vascular endothelial growth factor in pg/ml

  2. incidence of hydrothorax [ Time Frame: up to 1 months ]
  3. incidence of liver dysfunction [ Time Frame: up to 1 months ]
  4. incidence of renal dysfunction [ Time Frame: up to 1 months ]
  5. incidence of electrolytic imbalance [ Time Frame: up to 1 months ]
  6. incidence of hemoconcentration [ Time Frame: up to 1 months ]
  7. incidence of elevated WBC [ Time Frame: up to 1 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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
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Responsible Party: Zhou Canquan, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University Identifier: NCT02670304    
Other Study ID Numbers: 28843020
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to make IPD available
Keywords provided by Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University:
ovarian hyperstimulating syndrome
Additional relevant MeSH terms:
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Ovarian Hyperstimulation Syndrome
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists