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Efficacy and Safety of Dexamethasone Prevention for Patients of Ovarian Hyperstimulation Syndrome

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ClinicalTrials.gov Identifier: NCT02846493
Recruitment Status : Unknown
Verified July 2016 by Yanhong Deng, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Yanhong Deng, Sun Yat-sen University

Brief Summary:
This prospective, randomized, controlled clinical trial will evaluate the effect and security of dexamethasone prevention for Patients of Ovarian Hyperstimulation Syndrome.

Condition or disease Intervention/treatment Phase
Ovarian Hyperstimulation Syndrome Drug: bromocriptine Drug: dexamethasone Phase 2

Detailed Description:
Ovarian hyperstimulation syndrome (OHSS) is a iatrogenic complication of ovarian stimulation,which in its severe form is associated with significant morbidity and can be life threatening. It is characterized by cystic enlargement of the ovaries and rapid fluid shifts from the intravascular compartment to the third space. It is thought that increased vascular permeability is the pivotal mechanism of OHSS pathophysiology. The administration of human chorionic gonadotrophin results in the release of vasoactive substance such as vascular endothelial growth factor that causes vasodilation and leakage of fluids. Glucocorticoids and their synthetic derivatives have an inhibitory effect on the VEGF gene expression in vascular smooth muscle cells. By reducing leukocytic infiltration and the release of inflammatory mediator, inhibiting vasodilation and preventing increases in vascular permeability, these agents can dampen the inflammatory response and prevent edema formation ,thus offering a potential therapeutic intervention for OHSS. Investigators have observed more than a hundred patients in clinical practice that low-dose dexamethasone has prevention action for patients in IVF cycles at high risk of OHSS. This clinical trial is designed to evaluate the effect and security of dexamethasone prevention for patients of Ovarian Hyperstimulation Syndrome. There are two groups: bromocriptine group, dexamethasone group .After followed-up for 7 days , Clinical OHSS parameters will be collected at oocyte retrieval and at the 4rd d and 6th d of treatment .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Dexamethasone Prevention for Patients of Ovarian Hyperstimulation Syndrome —— A Prospective, Randomized, Controlled Clinical Trial
Study Start Date : August 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Active Comparator: bromocriptine group
Rectal bromocriptine (2.5 mg, qd) for 7 days
Drug: bromocriptine
Patients in this group will receive rectal bromocriptine at a daily dose of 2.5 mg for 7 days,from the day of oocyte pickup.At oocyte retrieval and at the 3rd d and 5th d of treatment, all the patients received the measurements of body mass index (BMI), abdominal circumference (AC), maximum depth of ascites in ultrasonic (D),hepatorenal function, coagulation function ,white blood cell count (WBC), hematocrit (HCT), Vascular Endothelial Growth Factor(VEGF),drink intake (Intake) and urine volume.

Experimental: dexamethasone group
Oral take dexamethasone(3mg,qd)for 7 days
Drug: dexamethasone
Patients in this group will take oral dexamethasone at a daily dose of 3mg for 7 days,from the day of oocyte pickup.At oocyte retrieval and at the 3rd d and 5th d of treatment, all the patients received the measurements of body mass index (BMI), abdominal circumference (AC), maximum depth of ascites in ultrasonic (D),hepatorenal function, coagulation function ,white blood cell count (WBC), hematocrit (HCT),Vascular Endothelial Growth Factor(VEGF), drink intake (Intake) and urine volume.




Primary Outcome Measures :
  1. Incidence of moderate and severe OHSS [ Time Frame: 7 days ]
    Moderate OHSS is characterized by the presence of ascites on ultrasound examination ,moderate hemoconcentration and elevated leukocytes.Symptoms include abdominal distension , nausea and vomiting . And diagnosis of severe OHSS required clinical evidence of ascites or hydrothorax or breathing difficulties or one of the following criteria: 1) increased blood viscosity i.e. hemoglobin at least 15 gm%, hematocrit at least 45%, or leucocyte count at least 20,000 per cubic millimeter. 2) coagulation abnormality.3) liver dysfunction, defined when transaminases (AST or ALT) are more than 40 u/ml.


Secondary Outcome Measures :
  1. Adverse side effects of treatment [ Time Frame: 7 days ]
    Number of participants with treatment-related adverse events as assessed by CTCAE V4.0.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion Criteria:

    • Women of reproductive age
    • Women having controlled ovarian hyperstimulation as part of any assisted reproductive technique
    • Women at risk of severe OHSS(serum estradiol levels were>3000pg/ml on the day of HCG trigger ; there was retrieval of 20 or more oocytes)
  • Exclusion Criteria:

    • Unwillingness to comply with the study protocol.
    • Attending other clinical trials in the same period.
    • Chronic glucocorticoid their synthetic derivatives intake.
    • History of allergic to study medications.
    • The patients who cannot take dexamethasone.: hypertension, diabetes,gastric ulcer; abnormal renal or hepatic function and so on.

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): NCT02846493


Contacts
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Contact: Haitao Zeng, M.D. & Ph.D. 020-38048012 zenghaitao@163.com

Locations
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China, Guangdong
The Sixth Affiliated Hospital,Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510655
Contact: Haitao Zeng, M.D. & Ph.D.    020-38048012    zenghaitao@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Haitao Zeng Reproductive medicine center , 6th Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: Yanhong Deng, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02846493     History of Changes
Other Study ID Numbers: SYSU-ohss-001
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Keywords provided by Yanhong Deng, Sun Yat-sen University:
Ovarian hyperstimulation syndrome
Dexamethasone
Additional relevant MeSH terms:
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Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Syndrome
Disease
Pathologic Processes
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Dexamethasone
Dexamethasone acetate
Bromocriptine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents
Hormone Antagonists