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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02846493

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

9.1

Patients Per Site Per Month

Study Details

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.

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 .

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of moderate and severe OHSS [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

Adverse side effects of treatment [7 days]
Number of participants with treatment-related adverse events as assessed by CTCAE V4.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.