Ovarian Hyperstimulation Syndrome Prevention | NCT06739759

Studies
Ovarian Hyperstimulation Syndrome Prevention

NCT06739759

Sponsor

Aljazeera Hospital

Status

Recruiting

Last Update Posted

Dec 18, 2024Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Ovarian Hyper Stimulation Syndrome (OHSS)

Interventions

Antagonist protocol for IVF
Modified Agonist protocol for IVF with additive treatments as HCQ

Countries

Egypt

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2024Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Jul 30, 2025Estimated

First Submitted Date

Oct 23, 2024

First Submission Date that Met QC Criteria

Dec 13, 2024

First Posted Date

Dec 18, 2024Actual

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

Dec 13, 2024

Last Update Posted Date

Dec 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ovarian hyperstimulation is a very hazardous complication of ICSI

Detailed Description

Ovarian hyperstimulation could be mild , moderate , severe or marked

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
antagonist	Active Comparator	patients with PCOS undergoing ICSI receiving antagonist protocol	Drug: Antagonist protocol for IVF
Modified agonist with additives	Active Comparator	Patients with PCOS undergoing ICSI receiving modified agonist protocol with additives	Drug: Modified Agonist protocol for IVF with additive treatments as HCQ

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antagonist protocol for IVF	Drug	antagonist protocol with triggering by Decapeptyl	antagonist

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevention of OHSS	prevention of symptoms of ovarian hyperstimulation syndrome as amount of ascites in litres by US	within 3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with PCOS coming for ICSI

Exclusion Criteria:

Women who donnot have PCOS

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women with PCOS coming for ICSI

Minimum Age

19 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Alalfy, MD	Contact	01002611058		mahmoudalalfy@ymail.com
Ahmed Elgazzar, MD	Contact	01014005959		elgazzara50@gmail.com

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy, MD	Aljazeera Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aljazeerah hospital	Recruiting	Giza		12345	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006886	Hydroxychloroquine

Ancestor Terms

ID	Term
D002738	Chloroquine
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided