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

Fertility Disorders Clinical Trial

Official title:

Comparative Study Between Granulocyte Colony Stimulating Factor and Human Chorionic Gonadotropin in Patients With History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection (at Ovum Pick up Day)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04604054
• Other study ID #: 000000415
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: January 10, 2021

Study information

• Verified date: October 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 10, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• Females suffering from recurrent implantation failure and undergoing ICSI

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fertility Disorders

Intervention

Drug:
• Granulocyte Colony Stimulated Factor
GCSF was intrauterine injected once at ovum pick up day
• Human Chorionic Gonadotropins
500 IU of HCG was injected intrauterine once at ovum pick up day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate	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)	after 14 days from positive pregnancy test
Secondary	ultrasound image of Gestational sac	The gestational sac (GS) is the first sign of early pregnancy on ultrasound	6 weeks of pregnancy