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Status unknownNCT04606082Updated Oct 28, 2020

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

An interventional study of Granulocyte Colony Stimulated Factor and Human Chorionic Gonadotropins in Fertility Disorders, sponsored by Al-Azhar University. Status unknown. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-10-28.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Fertility Disorders
03

In context

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Females suffering from recurrent implantation failure and undergoing ICSI

Exclusion criteria

Exclusion Criteria:

  • presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Group 1

    Granulocyte Colony Stimulated Factor was intrauterine injected once at ovum pick up day

    Drug: Granulocyte Colony Stimulated Factor

  • Active comparator
    Group 2

    500 IU Human Chorionic Gonadotropins was injected intrauterine once at ovum pick up day

    Drug: Human Chorionic Gonadotropins

Interventions

  • DrugGranulocyte Colony Stimulated Factor

    GCSF was intrauterine injected once at ovum pick up day

    Also known as: GCSF, Neupogen, Granix and Zarxio

  • DrugHuman Chorionic Gonadotropins

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

    Also known as: HCG, Novarel, and Pregnyl

06

What researchers measure

Primary outcomes

  1. clinical pregnancy rate

    Clinical pregnancy was evaluated by high HCG levels

    Time frame: after 14 days from positive pregnancy test

Secondary outcomes

  1. Gestational sac imaging

    ultrasound imaging of Gestational sac after 6 weeks of pregnancy

    Time frame: 6 weeks of pregnancy

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04606082
Lead sponsor
Al-Azhar University
Responsible party
Elsayed Eldesouky (Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo, Al-Azhar University) — Principal investigator
First posted
Oct 28, 2020
Start date
Oct 30, 2020 (estimated)
Primary completion
Jan 10, 2021 (estimated)
Completion
Jan 10, 2021 (estimated)
Last update
Oct 28, 2020

Study contacts

Elsayed Eldesouky
Contact
elsayedeldesouky@yahoo.com
00201092934978
Elsayed Eldesouky
principal investigator · Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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