The Effect of Granulocyte Colony Stimulating Factor Versus Human Chorionic Gonadotropin in Females With a History of RIF
October 22, 2020 updated by: Elsayed Eldesouky, Al-Azhar University
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)
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Granulocyte Colony Stimulating Factor as a treatment.
|
GCSF was intrauterine injected once at ovum pick up day
Other Names:
|
|
Active Comparator: Group 2
Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Human Chorionic Gonadotropin as a treatment.
|
500 IU of HCG was injected intrauterine once at ovum pick up day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical pregnancy rate
Time Frame: 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)
|
after 14 days from positive pregnancy test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ultrasound image of Gestational sac
Time Frame: 6 weeks of pregnancy
|
The gestational sac (GS) is the first sign of early pregnancy on ultrasound
|
6 weeks of pregnancy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 30, 2020
Primary Completion (Anticipated)
January 10, 2021
Study Completion (Anticipated)
January 10, 2021
Study Registration Dates
First Submitted
October 22, 2020
First Submitted That Met QC Criteria
October 22, 2020
First Posted (Actual)
October 27, 2020
Study Record Updates
Last Update Posted (Actual)
October 27, 2020
Last Update Submitted That Met QC Criteria
October 22, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000000415
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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