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The Effect of Granulocyte Colony Stimulating Factor Versus Human Chorionic Gonadotropin in Females With a History of RIF

NCT ID: NCT04604054

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2021-01-10

Brief Summary

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One hundred patients who suffered from recurrent implantation failure in intracytoplasmic sperm injection (ICSI) were allocated in the study. On ovum pick-up day, 50 of them were intrauterine injected with granulocyte colony-stimulating factor (G-CSF) and the other 50 were injected with intrauterine Human Chorionic Gonadotropins (HCG). The clinical pregnancy rate was evaluated as a primary outcome and ultrasound imaging of the gestational sac was evaluated as a secondary outcome

Detailed Description

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One hundred patients suffering from recurrent implantation failure in intracytoplasmic sperm injection (ICSI) were included in the study. The patients were randomly allocated into two groups. The intervention group consisted of 50 patients who received intrauterine injected with granulocyte colony-stimulating factor (G-CSF). The other group (the control group) consisted of 50 patients and injected with intrauterine Human Chorionic Gonadotropins (HCG). Both groups received the interventions at ovum pick-up day. The main outcome was the clinical pregnancy rate which has been evaluated after 2 weeks of the positive pregnancy test. The secondary outcome was an ultrasound image of the gestational sac after 6 weeks of pregnancy.

Conditions

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Fertility Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Granulocyte Colony Stimulating Factor as a treatment.

Group Type EXPERIMENTAL

Granulocyte Colony Stimulated Factor

Intervention Type DRUG

GCSF was intrauterine injected once at ovum pick up day

Group 2

Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Human Chorionic Gonadotropin as a treatment.

Group Type ACTIVE_COMPARATOR

Human Chorionic Gonadotropins

Intervention Type DRUG

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

Interventions

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Granulocyte Colony Stimulated Factor

GCSF was intrauterine injected once at ovum pick up day

Intervention Type DRUG

Human Chorionic Gonadotropins

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

Intervention Type DRUG

Other Intervention Names

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GCSF HCG

Eligibility Criteria

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Inclusion Criteria

* Females suffering from recurrent implantation failure and undergoing ICSI

Exclusion Criteria

* presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Elsayed Eldesouky

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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000000415

Identifier Type: -

Identifier Source: org_study_id