NCT06739759

Brief Summary

Ovarian hyperstimulation is a very hazardous complication of ICSI

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

November 17, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

October 23, 2024

Last Update Submit

December 13, 2024

Conditions

Ovarian Hyper Stimulation Syndrome (OHSS)

Keywords

OHSSmildModerateSevere

Outcome Measures

Primary Outcomes (1)

  • prevention of OHSS

    prevention of symptoms of ovarian hyperstimulation syndrome as amount of ascites in litres by US

    within 3 weeks

Study Arms (2)

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

Antagonist protocol for IVFDRUG

antagonist protocol with triggering by Decapeptyl

Also known as: Antagonist
antagonist
Modified Agonist protocol for IVF with additive treatments as HCQDRUG

giving additive drugs to agonist protocolas HCQ

Also known as: modified agonist with additives
Modified agonist with additives

Eligibility Criteria

Age19 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with PCOS coming for ICSI
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with PCOS coming for ICSI

You may not qualify if:

  • Women who donnot have PCOS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aljazeerah hospital

Giza, 12345, Egypt

RECRUITING

Algazeerah

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mahmoud Alalfy, MD

    Aljazeera Hospital

    STUDY CHAIR

Central Study Contacts

Mahmoud Alalfy, MD

CONTACT

01002611058mahmoudalalfy@ymail.com

Ahmed Elgazzar, MD

CONTACT

01014005959elgazzara50@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Research centre

Study Record Dates

First Submitted

October 23, 2024

First Posted

December 18, 2024

Study Start

November 17, 2024

Primary Completion

June 30, 2025

Study Completion

July 30, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)