Clinical trial NCT02846493: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: Ovarian hyperstimulation syndrome
Dexamethasone
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: Incidence of moderate and severe OHSS
timeFrame: 7 days
Secondary outcomes:
measure: Adverse side effects of treatment
timeFrame: 7 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital,Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Reproductive medicine center , 6th Affiliated Hospital, Sun Yat-Sen University
name: Haitao Zeng
role: PRINCIPAL_INVESTIGATOR
References: