Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280560
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-15
Brief Title:
Impact of IVF Hormonal Therapy on Endometrial Receptivity and Endometrial Senescent Cell Pathological Accumulation
Sponsor:
Fundación IVI
Organization:
Fundación IVI
Study Overview
Official Title:
Impact of Controlled Ovarian Stimulation and Luteal Phase Support on Endometrial Receptivity and Endometrial Senescent Cell Pathological Accumulation Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
HormoSenoRec
Brief Summary:
Both controlled ovarian stimulation COS and frozen embryo transfer has become an integral part of in vitro fertilization IVF treatment Fresh embryo transfer is usually performed by providing Luteal Phase Support LPS with progesterone after COS Frozen embryo transfer FET is usually performed in artificial cycles with hormone replacement treatment HRT in which exogenous progesterone is administered although it can also be performed in a Natural Cycle without hormone supplementation NC There is evidence that the supraphysiologic levels of estradiol and progesterone during COSLPS and HRT could lead to morphologic and biochemical endometrial modifications altering endometrial receptivity and lowering implantation and pregnancy rates
We hypothesize that the supraphysiologic hormone levels required for both COSLPS and HRT may be inducing alterations in endometrial composition and function specifically the chronic accumulation of senescent cells either due to an excessive hormonal induction a lack of clearance due to a deficit of uNKs or a combination of both ultimately affecting both endometrial receptivity and decidualization worsening IVF outcomes
The in vitro clearance of endometrial senescent cells by selective induction of apoptosis has been found to enhance the decidualization capacity of the rest of Endometrial Stromal Cells EnSC which could represent in a future adjuvant strategy to reduce the potentially deleterious effects of supraphysiologic hormone levels and improve reproductive outcomes in IVF patients
The results derived from this project would have a direct impact on clinical practice First the results would allow us to evaluate based on experimental data potential endometrial side effects of stimulation protocols commonly used in IVF treatments In addition in the case of finding a pathological accumulation of senescent cells affecting endometrial receptivity we will be able to in vitro evaluate the effectiveness of adjuvant senolytic drugs designed to specifically remove senescent cells compounds to in vitro improve the expression of endometrial receptivity markers as a first step to demonstrate the effectiveness of their use in improving the reproductive outcomes of IVF patients
We hypothesize that the supraphysiologic hormone levels required for both COSLPS and HRT may be inducing alterations in endometrial composition and function specifically the chronic accumulation of senescent cells either due to an excessive hormonal induction a lack of clearance due to a deficit of uNKs or a combination of both ultimately affecting both endometrial receptivity and decidualization worsening IVF outcomes
The in vitro clearance of endometrial senescent cells by selective induction of apoptosis has been found to enhance the decidualization capacity of the rest of Endometrial Stromal Cells EnSC which could represent in a future adjuvant strategy to reduce the potentially deleterious effects of supraphysiologic hormone levels and improve reproductive outcomes in IVF patients
The results derived from this project would have a direct impact on clinical practice First the results would allow us to evaluate based on experimental data potential endometrial side effects of stimulation protocols commonly used in IVF treatments In addition in the case of finding a pathological accumulation of senescent cells affecting endometrial receptivity we will be able to in vitro evaluate the effectiveness of adjuvant senolytic drugs designed to specifically remove senescent cells compounds to in vitro improve the expression of endometrial receptivity markers as a first step to demonstrate the effectiveness of their use in improving the reproductive outcomes of IVF patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PI2300860 | OTHER_GRANT | Instituto de Salud Carlos III co-funded by European Union | None |