Infertility Clinical Trial
Official title:
The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes
The goal of this clinical trial is to test the effect of granulocyte colony-stimulating factor (G-CSF, A.K.A. Filgrastim) in infertility patients undergoing in vitro fertilization (IVF) treatment. The main question it aims to answer is: Can in vitro fertilization-embryo transfer (IVF-ET) outcomes be improved by supplementing the transfer media with Granulocyte colony-stimulating factor (GCSF)? Participants will undergo their embryo transfer as per the normal clinic protocol but will be randomized to either receive the standard embryo transfer media or the GCSG-supplemented transfer media. Researchers will compare the GCSF and standard transfer media groups to see if clinical outcomes are improved (i.e., implantation rate, pregnancy, clinical pregnancy rate, live birth rate).
Status | Recruiting |
Enrollment | 300 |
Est. completion date | January 10, 2025 |
Est. primary completion date | January 10, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 38 Years |
Eligibility | Inclusion Criteria: - Recruited subjects will either be undergoing a fresh IVF-ET cycle in which the embryo(s) generated from the initial treatment cycle are transferred during that same cycle (i.e., on day 5 or 6 post-egg retrieval) or an FET cycle in which the embryo(s) transferred were generated in a previous IVF cycle and were cryopreserved for subsequent warming and transfer. Exclusion Criteria: - Patients with uterine factor or severe male factor infertility will be excluded. - Patients who have had previous IVF failures will be excluded. |
Country | Name | City | State |
---|---|---|---|
Canada | Newlife Fertility Centre | Mississauga | Ontario |
Lead Sponsor | Collaborator |
---|---|
Newlife Fertility Centre |
Canada,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implantation Rate | Number of embryos implanted (i.e. number of gestational sacs observed under ultrasound guidance) divided by total number of embryos transferred | From enrollment to the time of 6-week ultrasound. | |
Primary | Clinical Pregnancy Rate | Number of patients with fetal heartbeats detected at time of 6-week ultrasound divided by the total number of patients in that group. | From enrollment to the time of 6-week ultrasound. | |
Primary | Pregnancy Rate | Number of patients with a positive beta-human chorionic gonadotropin (bhCG) pregnancy blood test at 10 days post-ET divided by the total number of patients in that group. | From enrollment to the time of blood test at 10 days post-ET. | |
Primary | Live Birth Rate | Total Number of infants born divided by the total number of embryo transfers performed (i.e., patients) in that group. | From enrollment to the time of birth (up to 9-months post-ET). | |
Secondary | Spontaneous Abortion Rate | Number of patients with a confirmed clinical pregnancy who lost their pregnancy before 20 weeks of gestation divided by the total number of patients with confirmed clinical pregnancies. | From enrollment to the time of pregnancy loss (up to 20 weeks post-ET). | |
Secondary | Biochemical Pregnancy Rate | Number of patients who had a positive beta-human chorionic gonadotropin (bhCG) pregnancy blood test at 10 days post-ET but that did not display a gestational sac/fetal heartbeat at 6-week ultrasound, divided by the total number of patients in that group. | From enrollment to the time of 6-week ultrasound. |
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