Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117982
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2023-10-31
Brief Title:
The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency
Sponsor:
Trio Fertility
Organization:
Trio Fertility
Study Overview
Official Title:
Does Subcutaneous Granulocyte Colony Stimulating Factor G-CSF Improve Ovarian Reserve in Women With Premature Ovarian Insufficiency
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this pilot study is to improve ovarian reserve markers in patients with premature ovarian insufficiency The main question it aims to answer is
- Will treatment with G-CSF allow improvement in markers of ovarian reserve
- Will treatment with G-CSF allow improvement in markers of ovarian reserve
Detailed Description:
The research team hypothesize that treatment of premature ovarian insufficiency patients with G-CSF to mobilize bone marrow hematopoietic stem cells will allow for improved ovarian reserve markers including antral follicle count anti-Mullerian hormone AMH levels and gonadotropin FSH levels The research team anticipate these outcomes
Primary outcome Decreased serum FSH and increased AMH levels and us measurement of increased antral follicle count AFC
Secondary outcome Improved ovarian response in IVF cycles if BAFs develop and spontaneous or IVF pregnancy
Primary outcome Decreased serum FSH and increased AMH levels and us measurement of increased antral follicle count AFC
Secondary outcome Improved ovarian response in IVF cycles if BAFs develop and spontaneous or IVF pregnancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None