Human Chorionic Gonadotropin Versus Granulocyte Colony St... | NCT04606082

Studies
Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor in Increasing Pregnancy Rate in ICSI

NCT04606082

Sponsor

Al-Azhar University

Status

Unknown status

Last Update Posted

Oct 28, 2020Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Fertility Disorders

Interventions

Granulocyte Colony Stimulated Factor
Human Chorionic Gonadotropins

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2020Estimated

Primary Completion Date

Jan 10, 2021Estimated

Completion Date

Jan 10, 2021Estimated

First Submitted Date

Oct 23, 2020

First Submission Date that Met QC Criteria

Oct 23, 2020

First Posted Date

Oct 28, 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

Oct 23, 2020

Last Update Posted Date

Oct 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elsayed Eldesouky, Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo, Al-Azhar UniversityPrincipal Investigator

Lead Sponsor

Al-Azhar UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Intrauterine Granulocyte colony stimulating factor (GCSF) was compared with intrauterine Human Chorionic Gonadotropin (HCG) in increasing clinical pregnancy rate as a primary outcome and ultrasound imaging of gestational sac as a secondary outcome.

Detailed Description

Two hundred females with history of recurrent implantation failure and undergoing Intracytoplasmic Sprem injection (ICSI) were randomized into two groups; the first group (100 patients) received intrauterine Granulocyte colony stimulating factor (GCSF) and the second group (100) received intrauterine Human Chorionic Gonadotropin (HCG) at ovum pick up day. The clinical pregnancy rate was evaluated as a primary outcome after 14 days and ultrasound imaging of gestational sac was evaluated as a secondary outcome after 6 weeks.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	Granulocyte Colony Stimulated Factor was intrauterine injected once at ovum pick up day	Drug: Granulocyte Colony Stimulated Factor
Group 2	Active Comparator	500 IU Human Chorionic Gonadotropins was injected intrauterine once at ovum pick up day	Drug: Human Chorionic Gonadotropins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Granulocyte Colony Stimulated Factor	Drug	GCSF was intrauterine injected once at ovum pick up day	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate	Clinical pregnancy was evaluated by high HCG levels	after 14 days from positive pregnancy test

Secondary Outcomes

Measure	Description	Time Frame
Gestational sac imaging	ultrasound imaging of Gestational sac after 6 weeks of pregnancy	6 weeks of pregnancy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females suffering from recurrent implantation failure and undergoing ICSI

Exclusion Criteria:

presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elsayed Eldesouky	Contact	00201092934978		elsayedeldesouky@yahoo.com

Overall Officials

Name	Affiliation	Role
Elsayed Eldesouky	Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069585	Filgrastim
D006063	Chorionic Gonadotropin

Ancestor Terms

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided