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

NCT ID: NCT04606082

Last Updated: 2020-10-28

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2021-01-10

Brief Summary

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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

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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.

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

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

Group Type EXPERIMENTAL

Granulocyte Colony Stimulated Factor

Intervention Type DRUG

GCSF was intrauterine injected once at ovum pick up day

Group 2

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

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, Neupogen, Granix and Zarxio HCG, Novarel, and Pregnyl

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

Principal Investigators

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Elsayed Eldesouky

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

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Elsayed Eldesouky

Role: CONTACT

[email protected]
00201092934978

Other Identifiers

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Gyne_415

Identifier Type: -

Identifier Source: org_study_id