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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-06-30

Brief Summary

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

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Detailed Description

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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 .

Conditions

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Ovarian Hyperstimulation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bromocriptine group

Rectal bromocriptine (2.5 mg, qd) for 7 days

Group Type ACTIVE_COMPARATOR

bromocriptine

Intervention Type DRUG

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.

dexamethasone group

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

Group Type EXPERIMENTAL

dexamethasone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No