NCT04606082

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Status
unknown

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, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2021

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 23, 2020

Last Update Submit

October 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    Clinical pregnancy was evaluated by high HCG levels

    after 14 days from positive pregnancy test

Secondary Outcomes (1)

  • Gestational sac imaging

    6 weeks of pregnancy

Study Arms (2)

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

GCSF was intrauterine injected once at ovum pick up day

Also known as: GCSF, Neupogen, Granix and Zarxio
Group 1

500 IU of HCG was injected intrauterine once at ovum pick up day

Also known as: HCG, Novarel, and Pregnyl
Group 2

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females suffering from recurrent implantation failure and undergoing ICSI

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

FilgrastimChorionic Gonadotropin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPregnancy Proteins

Study Officials

  • Elsayed Eldesouky

    Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 28, 2020

Study Start

October 30, 2020

Primary Completion

January 10, 2021

Study Completion

January 10, 2021

Last Updated

October 28, 2020

Record last verified: 2020-10