Dual Trigger, Urinary HCG or Recombinant HCG, Which is th... | NCT04265495

Studies
Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !?

NCT04265495

Sponsor

Al Baraka Fertility Hospital

Status

Unknown status

Last Update Posted

Sep 28, 2021Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Interventions

Not provided

Countries

Bahrain

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

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2020Actual

Primary Completion Date

Nov 30, 2021Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Feb 9, 2020

First Submission Date that Met QC Criteria

Feb 9, 2020

First Posted Date

Feb 11, 2020Actual

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

Sep 27, 2021

Last Update Posted Date

Sep 28, 2021Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome of ICSI- antagonist cycles

Detailed Description

a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome (oocyte quality, fertilization rate, implantation rate, clinical pregnancy rate as well as the incidence of OHSS) in ICSI- antagonist cycles

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DUAL TRIGGERING		PATIENTS WILL RECEIVE DUAL TRIGGERING
URINARY HCG		PATIENTS WILL RECEIVE URINARY HCG
RECOMBINANT HCG		PATIENTS WILL RECEIVE RECOMBINANT HCG

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate,		4 WEEKS
implantation rate,		2 WEEKS
incidence of OHSS.		1 WEEK

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients <40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol

Exclusion Criteria:

age: > 40 years
BMI > 30 ,
long agonist protocol
were chromosomal and genetic disorders, abnormal ultrasonogram of the uterine cavity

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

patients <40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol, then at the time of triggering, we divided the patients to 3 groups by for triggering by a dual trigger, urinary HCG and recombinant HCG and then will check the outcome regarding the maturity and oocyte quality, implantation rate, clinical pregnancy rate as well as incidence of OHSS

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kamal eldin Rageh, M.D.	Contact	0097333153871		dr_kamal_rageh@yahoo.com
Ahmed Barakat, FRCOG	Contact	0097317727888		ahmed.barakat@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-BARAKA FERTILITY HOSPITAL	Recruiting	Manama	Adliya	15006	Bahrain