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

Study Overview
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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.

Official Title
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Intra Uterine Injection of Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor at Ovum Pick up Day Significantly Increase Implantation Rate and Pregnancy Rate in Intra Cytoplasmic Sperm Injection

Conditions
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Fertility Disorders

Intervention / Treatment
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* Drug: Granulocyte Colony Stimulated Factor
* Drug: Human Chorionic Gonadotropins


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Granulocyte Colony Stimulated Factor was intrauterine injected once at ovum pick up day | Drug: Granulocyte Colony Stimulated Factor<br>* GCSF was intrauterine injected once at ovum pick up day<br>* Other names: GCSF, Neupogen, Granix and Zarxio;|
| Active Comparator: Group 2<br>500 IU Human Chorionic Gonadotropins was injected intrauterine once at ovum pick up day | Drug: Human Chorionic Gonadotropins<br>* 500 IU of HCG was injected intrauterine once at ovum pick up day<br>* Other names: HCG, Novarel, and Pregnyl;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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