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

Not Applicable

• Conditions: Fertility Disorders
• Interventions: Drug: Human Chorionic Gonadotropins; Drug: Granulocyte Colony Stimulated Factor

• Registration Number: NCT04606082
• Lead Sponsor: Al-Azhar University

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.

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.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-10-23
• Last Update Submitted: 2020-10-23
• Study First Posted: 2020-10-28
• Last Update Posted: 2020-10-28
• Study Start: 2020-10-30
• Primary Completion: 2021-01-10
• Study Completion: 2021-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Females suffering from recurrent implantation failure and undergoing ICSI

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Human Chorionic Gonadotropins	500 IU Human Chorionic Gonadotropins was injected intrauterine once at ovum pick up day
Group 1	Granulocyte Colony Stimulated Factor	Granulocyte Colony Stimulated Factor was intrauterine injected once at ovum pick up day

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	after 14 days from positive pregnancy test	Clinical pregnancy was evaluated by high HCG levels

Secondary Outcome Measures

Name	Time	Method
Gestational sac imaging	6 weeks of pregnancy	ultrasound imaging of Gestational sac after 6 weeks of pregnancy