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Patients will have ovarian PRP treatments and embryo development will be observed using time-lapse imaging and AI software.
. oPRP Treatment & Second IVF Cycle (Study Cycle)
Following the first IVF cycle, patients will undergo their first oPRP injection:
Second IVF Cycle (oPRP Study Cycle)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embryo Development Before and After Ovarian PRP Using Time-Lapse AI Embryo Quality Score | Experimental | Patients will undergo two IVF cycles. The first cycle will be before ovarian PRP treatment and the second will be after. The embryo development measured by data gathered in time-lapse imaging and AI software will be used to determine differences between the groups within the same patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ovarian Platelet-rich plasma (PRP) injections | Procedure | This is a procedure that our patients receive at our clinic. We want to use the AI software to evaluate embryo development before and after treatment to see if there is a difference in embryo quality after PRP treatment within the same patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Blastocyst formation and embryo quality | The number of high quality embryos that are created per cycle | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate per transfer | The number of live births following embryo transfer | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alicia L Broussard, PhD | Contact | 3174456958 | a.broussard@generationnextfertility.com | |
| Jesse Hade, MD | Contact | 2126410906 | j.hade@generationnextfertility.com |
| Name | Affiliation | Role |
|---|---|---|
| Jesse Hade, MD | Generation Next Fertility | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Generation Next Fertility | Recruiting | New York | New York | 10022 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2025 | Jun 2, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2025 | Jun 10, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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A NON-RANDOMIZED PROSPECTIVE SELF-CONTROLLED INTERVENTIONAL STUDY
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