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Preventive Application of GnRH Antagonist on Early OHSS

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ClinicalTrials.gov Identifier: NCT03188471
Recruitment Status : Unknown
Verified June 2017 by Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : June 15, 2017
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.

Condition or disease Intervention/treatment Phase
Ovarian Hyperstimulation Syndrome GnRH Antagonist Aspirin Vascular Endothelial Growth Factor Pigment Epithelium Derived Factor Drug: GnRH antagonist Drug: aspirin Phase 4

Detailed Description:
Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Early ovarian hyperstimulation syndrome (OHSS) occurs during luteal phase of controlled ovarian stimulation within 9 days after human chorionic gonadotropin trigger and reflects an acute consequence of this hormone on the ovaries.Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Recently the administration of GnRH antagonists during the luteal phase of in vitro fertilization cycles offers another therapeutic modality for patients with severe early OHSS.However, preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventive Application of GnRH Antagonist on Early Ovarian Hyperstimulation Syndrome in High-risk Women: A Prospective Randomized Trial
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: GnRH antagonist
Vitamin C (1 tablet daily) as placebo of aspirin GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days
Drug: GnRH antagonist
GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days for high risk of ovarian hyper stimulation syndrome patients
Other Name: Vitamin C platelet

Active Comparator: aspirin
aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days.
Drug: aspirin
aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days
Other Name: saline as placebo of GnRH antagonist




Primary Outcome Measures :
  1. Incidence and severity of early ovarian hyperstimulation syndrome [ Time Frame: up to 1 month ]
    Incidence and severity of early ovarian hyperstimulation syndrome according to its classification


Secondary Outcome Measures :
  1. vascular endothelial growth factor level [ Time Frame: up to 1 month ]
    VEGF level

  2. pigment epithelium derived factor level [ Time Frame: up to 1 month ]
    PEDF level

  3. incidence of hydrothorax [ Time Frame: up to 1 month ]
    one criterion for evaluation of OHSS severity

  4. incidence of liver dysfunction [ Time Frame: up to 1 month ]
    one criterion for evaluation of OHSS severity

  5. incidence of renal dysfunction [ Time Frame: up to 1 month ]
    one criterion for evaluation of OHSS severity

  6. incidence of electrolytic imbalance [ Time Frame: up to 1 month ]
    one criterion for evaluation of OHSS severity

  7. incidence of hemoconcentration [ Time Frame: up to 1 month ]
    one criterion for evaluation of OHSS severity

  8. incidence of elevated WBC [ Time Frame: up to 1 month ]
    one criterion for evaluation of OHSS severity



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • number of oocyte retrieval more than 25;
  • estradiol level higher than 5000pg/mL on the day of human chorionic gonadotropin administration;
  • clinical or ultrasonography proven ovarian hyperstimulation syndrome on the day of oocyte retrieval.

Exclusion Criteria:

  • contraindications to GnRH antagonist;
  • coasting or other preventive measures for managing ovarian hyperstimulation syndrome had been applied;
  • GnRH agonist for trigger.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188471


Contacts
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Contact: Canquan Zhou +86 20 87755766 ext 8362 zhoucanquan@hotmail.com

Locations
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China, Guangdong
The First Affiliated Hospital of Sun Yatsen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact       eoshappy@163.com   
Principal Investigator: Canquan Zhou         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Qingyun Mai Center for Reproductive Medicine and Department of Gynecology & Obstetrics, First Affiliated Hospital, Sun Yat-sen University
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Responsible Party: Zhou Canquan, Chief of the Center for Reproductive Medicine and Department of Gynecology & Obstetrics, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03188471    
Other Study ID Numbers: antagonist
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Hyperstimulation Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Aspirin
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics