Gonadotropin Releasing Hormone Antagonist in Treatment of... | NCT02784457

Studies
Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome

NCT02784457

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

May 27, 2016Estimated

Enrollment

84Actual

Phase

Phase 2

Conditions

Assisted Reproduction

Interventions

Cetrorelix

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Mar 2016Actual

First Submitted Date

May 23, 2016

First Submission Date that Met QC Criteria

May 24, 2016

First Posted Date

May 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2016

Last Update Posted Date

May 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Efficacy of the use of GnRH antagonist in treatment of those who develop early-onset severe ovarian hyperstimulation syndrome and had cancelled embryo transfer

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GnRHant	Active Comparator	women who received GnRH antagonist	Drug: Cetrorelix
Control	No Intervention	women who did not receive GnRH antagonist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetrorelix	Drug		GnRHant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of women who needed culdocentesis or paracentesis of the ascitic fluid		within 2 weeks of onset

Secondary Outcomes

Measure	Description	Time Frame
Number of women who needed hospitalization		within 2 weeks of onset of symptoms
Time to regression of nausea/vomiting		within 2 weeks of onset of symptoms
Time to regression of large ovarian size

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women who develop early-onset severe ovarian hyperstimulation syndrome after controlled ovarian stimulation using long GnRH agonist protocol and hCG for triggering ovulation.

Exclusion Criteria:

Women on short or antagonist protocols.
Women who received GnRH agonist for triggering ovulation.
Women who had embryo transfer.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C062876	cetrorelix

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided