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NCT04606082 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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