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

Not Applicable

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

• Registration Number: NCT04604054
• Lead Sponsor: Al-Azhar University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-22
• Last Update Submitted: 2020-10-22
• Study First Posted: 2020-10-27
• Last Update Posted: 2020-10-27
• Study Start: 2020-10-30
• Primary Completion: 2021-01-10
• Study Completion: 2021-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 1	Granulocyte Colony Stimulated Factor	Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Granulocyte Colony Stimulating Factor as a treatment.
Group 2	Human Chorionic Gonadotropins	Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Human Chorionic Gonadotropin as a treatment.

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	after 14 days from positive pregnancy test	number of pregnancies that is confirmed by both high levels of hCG (the pregnancy hormone) and ultrasound confirmation of a gestational sac or heartbeat (fetal pole)

Secondary Outcome Measures

Name	Time	Method
ultrasound image of Gestational sac	6 weeks of pregnancy	The gestational sac (GS) is the first sign of early pregnancy on ultrasound