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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Ovarian Hyperstimulation Syndrome

Treatments: Drug: bromocriptine; Drug: dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02846493

SYSU-ohss-001

Details and patient eligibility

About

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

Full 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 .

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

bromocriptine group

Active Comparator group

Description:

Rectal bromocriptine (2.5 mg, qd) for 7 days

Treatment:

Drug: bromocriptine

dexamethasone group

Experimental group

Description:

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

Treatment:

Drug: dexamethasone