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

Primary Purpose

Ovarian Hyperstimulation Syndrome

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
bromocriptine
dexamethasone
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Hyperstimulation Syndrome focused on measuring Ovarian hyperstimulation syndrome, Dexamethasone

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • The Sixth Affiliated Hospital,Sun Yat-Sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

bromocriptine group

dexamethasone group

Arm Description

Rectal bromocriptine (2.5 mg, qd) for 7 days

Oral take dexamethasone(3mg,qd)for 7 days

Outcomes

Primary Outcome Measures

Incidence of moderate and severe OHSS
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

Adverse side effects of treatment
Number of participants with treatment-related adverse events as assessed by CTCAE V4.0.

Full Information

First Posted
July 14, 2016
Last Updated
July 24, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02846493
Brief Title
Efficacy and Safety of Dexamethasone Prevention for Patients of Ovarian Hyperstimulation Syndrome
Official Title
Efficacy and Safety of Dexamethasone Prevention for Patients of Ovarian Hyperstimulation Syndrome -- A Prospective, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
Ovarian hyperstimulation syndrome, Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bromocriptine group
Arm Type
Active Comparator
Arm Description
Rectal bromocriptine (2.5 mg, qd) for 7 days
Arm Title
dexamethasone group
Arm Type
Experimental
Arm Description
Oral take dexamethasone(3mg,qd)for 7 days
Intervention Type
Drug
Intervention Name(s)
bromocriptine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
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 Measure Information:
Title
Incidence of moderate and severe OHSS
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Adverse side effects of treatment
Description
Number of participants with treatment-related adverse events as assessed by CTCAE V4.0.
Time Frame
7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haitao Zeng, M.D. & Ph.D.
Phone
020-38048012
Email
zenghaitao@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haitao Zeng
Organizational Affiliation
Reproductive medicine center , 6th Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sixth Affiliated Hospital,Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haitao Zeng, M.D. & Ph.D.
Phone
020-38048012
Email
zenghaitao@163.com

12. IPD Sharing Statement

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

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