NCT02846493

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

July 14, 2016

Last Update Submit

July 24, 2016

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

Ovarian hyperstimulation syndromeDexamethasone

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days

Secondary Outcomes (1)

  • Adverse side effects of treatment

    7 days

Study Arms (2)

bromocriptine group

ACTIVE COMPARATOR

Rectal bromocriptine (2.5 mg, qd) for 7 days

Drug: bromocriptine

dexamethasone group

EXPERIMENTAL

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

Drug: dexamethasone

Interventions

bromocriptineDRUG

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.

bromocriptine group
dexamethasoneDRUG

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.

dexamethasone group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sixth Affiliated Hospital,Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

BromocriptineDexamethasone

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ErgotaminesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsErgolinesHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Haitao Zeng

    Reproductive medicine center , 6th Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haitao Zeng, M.D. & Ph.D.

CONTACT

020-38048012zenghaitao@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 27, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

CN(1)