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

Fertility Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04606082
• Other study ID #: Gyne_415
• 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: Elsayed Eldesouky
• Phone: 00201092934978
• Email: elsayedeldesouky[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• 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	Clinical pregnancy was evaluated by high HCG levels	after 14 days from positive pregnancy test
Secondary	Gestational sac imaging	ultrasound imaging of Gestational sac after 6 weeks of pregnancy	6 weeks of pregnancy