Clinical trial NCT06174298: The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes
Official title: The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infertility
Infertility,Female
Infertility; Female, Nonimplantation
Infertility Unexplained
Infertility of Uterine Origin
Keywords: Infertility
Embryo Transfer
GCSF
Granulocyte Colony-Stimulating Factor
Filgrastim
Neupogen
Implantation
Lead sponsor: Newlife Fertility Centre
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implantation Rate
timeFrame: From enrollment to the time of 6-week ultrasound.
measure: Clinical Pregnancy Rate
timeFrame: From enrollment to the time of 6-week ultrasound.
measure: Pregnancy Rate
timeFrame: From enrollment to the time of blood test at 10 days post-ET.
measure: Live Birth Rate
timeFrame: From enrollment to the time of birth (up to 9-months post-ET).
Secondary outcomes:
measure: Spontaneous Abortion Rate
timeFrame: From enrollment to the time of pregnancy loss (up to 20 weeks post-ET).
measure: Biochemical Pregnancy Rate
timeFrame: From enrollment to the time of 6-week ultrasound.
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Newlife Fertility Centre
state: Ontario
Study officials:
affiliation: Newlife Fertility Centre
name: Samuel Soliman, M.D.
role: PRINCIPAL_INVESTIGATOR
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