Infertility, Infertility,Female, Infertility; Female, Nonimplantation, Infertility of Uterine Origin, Infertility Unexplained
Conditions
Keywords
Infertility, Embryo Transfer, GCSF, Granulocyte Colony-Stimulating Factor, Filgrastim, Neupogen, Implantation
Brief summary
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).
Detailed description
Please see uploaded study protocol.
Interventions
Intervention Group Fresh Embryo Transfers: On day 5 or 6 of culture, viable embryos will be transferred into a center-well dish containing 1 mL of embryo transfer media supplemented with GCSF. The embryos will be cultured in this medium for approximately 3 hours before the embryo transfer (ET) procedure. During the ET procedure, the same media will be used to fill the ET syringe and catheter that will be used to deposit the embryos into the uterus by the physician. Intervention Group Frozen Embryo Transfers: Cryopreserved embryos will be thawed according to the Kitazato thawing protocol and will be subsequently transferred to a center-well dish containing 1 mL of embryo transfer media supplemented with GCSF. The embryos will be cultured in this medium for approximately 3 hours before the ET procedure. During the ET procedure, the same media will be used to fill the ET syringe and catheter that will be used to deposit the embryos into the uterus by the physician.
OTHERStandard Embryo Transfer Media
Control Group Fresh Embryo Transfers: On day 5 or 6 of culture, viable embryos will be transferred into a center-well dish containing 1 mL of embryo transfer media. The embryos will be cultured in this medium for approximately 3 hours before the embryo transfer (ET) procedure. During the ET procedure, the same media will be used to fill the ET syringe and catheter that will be used to deposit the embryos into the uterus by the physician. Control Group Frozen Embryo Transfers: Cryopreserved embryos will be thawed according to the Kitazato thawing protocol and will be subsequently transferred to a center-well dish containing 1 mL of embryo transfer media. The embryos will be cultured in this medium for approximately 3 hours before the ET procedure. During the ET procedure, the same media will be used to fill the ET syringe and catheter that will be used to deposit the embryos into the uterus by the physician.
Sponsors
Newlife Fertility Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implantation Rate | From enrollment to the time of 6-week ultrasound. | Number of embryos implanted (i.e. number of gestational sacs observed under ultrasound guidance) divided by total number of embryos transferred |
| Clinical Pregnancy Rate | From enrollment to the time of 6-week ultrasound. | Number of patients with fetal heartbeats detected at time of 6-week ultrasound divided by the total number of patients in that group. |
| Pregnancy Rate | From enrollment to the time of blood test at 10 days post-ET. | 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. |
| Live Birth Rate | From enrollment to the time of birth (up to 9-months post-ET). | Total Number of infants born divided by the total number of embryo transfers performed (i.e., patients) in that group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous Abortion Rate | From enrollment to the time of pregnancy loss (up to 20 weeks post-ET). | 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. |
| Biochemical Pregnancy Rate | From enrollment to the time of 6-week ultrasound. | 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. |
Countries
Canada
Contacts
Primary ContactSamuel Soliman, M.D.
Backup ContactDavid Soliman, M.Sc.
Outcome results
None listed