Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665232
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2016-02-25
Brief Title:
Immunomodulatory Effects of Subcutaneous Progesterone in Patients Affected by Autoimmune Diseases
Sponsor:
San Carlo Public Hospital Potenza Italy
Organization:
San Carlo Public Hospital Potenza Italy
Study Overview
Official Title:
Immunomodulatory Effects of Subcutaneous Progesterone in Patients Undergoing IVF Affected by Autoimmune Diseases
Status:
COMPLETED
Status Verified Date:
2024-05
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:
This study evaluates the immunomodulatory effects of subcutaneous progesterone in patients undergoing IVF by determination of anti-nuclear antibodies ANAextractable nuclear antigen antibodies ENAanti- neutrophil cytoplasmic antibodiesANCAanti-DNA antibodies anti-cardiolipin antibodies ACALupus anticoagulant antibodies LAC and C3 and C4 fractions of complement on the day of beta hCG dosage and during the eigth week of gestation
Detailed Description:
The aqueous progesterone preparation for sc injection is the first systemic progesterone of its kind for the provision of luteal phase support LPS in patients undergoing IVF
The the high solubility and rapid absorption of the new preparation are enhanced using cyclodextrins that are starch residues with no therapeutic activity and with a particular molecular structure that closely resembles a cap
Once absorbed after injection the progesterone molecule is immediately dissociated from its cyclodextrin cap remaining free in the circulation as if produced endogenously by the ovaries
In comparison to progesterone-in-oil preparation the new aqueous solution administered by scroute resulted in a 3 fold higher and more rapid progesterone peak serum concentrations
The immunomodulating effects of progesterone are mediated outside of the pelvic cavity on the peripheral cell of the immune system For this reason only the injection procedure has this advantage Furthermore the faster absorption rate and the higher peak serum concentration should increas the systemic immunomodulatory effect of subcutaneous progesterone compared to the vaginal and intramuscular administration
The the high solubility and rapid absorption of the new preparation are enhanced using cyclodextrins that are starch residues with no therapeutic activity and with a particular molecular structure that closely resembles a cap
Once absorbed after injection the progesterone molecule is immediately dissociated from its cyclodextrin cap remaining free in the circulation as if produced endogenously by the ovaries
In comparison to progesterone-in-oil preparation the new aqueous solution administered by scroute resulted in a 3 fold higher and more rapid progesterone peak serum concentrations
The immunomodulating effects of progesterone are mediated outside of the pelvic cavity on the peripheral cell of the immune system For this reason only the injection procedure has this advantage Furthermore the faster absorption rate and the higher peak serum concentration should increas the systemic immunomodulatory effect of subcutaneous progesterone compared to the vaginal and intramuscular administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None