Ignite Creation Date:
2024-05-06 @ 1:43 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04107129
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2019-09-17
Brief Title:
Predicting Endometrial Receptivity for Optimal Reproductive Management
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Predicting Endometrial Receptivity for Optimal Reproductive Management PERFORM
Status:
COMPLETED
Status Verified Date:
2023-07
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:
PERFORM
Brief Summary:
The purpose of this study is to understand why some women are infertile unable to conceive a child The investigators hope to learn if an endometrial biopsy after egg retrieval is feasible for detecting biomarkers for endometriosis and predicting implantation and pregnancy rate after embryo transfer
This study design will provide for the first time an opportunity to compare endometrial biopsy material from hyperstimulated gonadotropin treated subjects after egg retrieval If successful it would provide a new protocol for women with unexplained infertility or those with known endometriosis to avoid poor IVF outcomes
This study design will provide for the first time an opportunity to compare endometrial biopsy material from hyperstimulated gonadotropin treated subjects after egg retrieval If successful it would provide a new protocol for women with unexplained infertility or those with known endometriosis to avoid poor IVF outcomes
Detailed Description:
The investigators will recruit 100 women who are undergoing IVF with egg retrieval and delayed embryo transfer to consent to endometrial biopsy 1 week after egg retrieval Currently most women in the Stanfords IVF program undergo egg retrieval with delayed embryo transfer ET with preimplantation genetic testing of embryos This delay allows most to avoid the condition known as ovarian hyperstimulation and allows time for genetic screening PGT-A performed on embryos Such a delay also opens the window for endometrial assessment for proteins like SIRT1 and BCL6 that have been suggested to be associated with endometriosis Endometriosis is thought to cause IVF failure Littman et al 2002 by treating endometriosis in the future clinicians might avoid IVF failure due to an unexpected non-receptive endometrium Littman et al 2002 This study design will provide for the first time an opportunity to compare endometrial biopsy material from hyperstimulated gonadotropin treated subjects after egg retrieval If successful it would provide a new protocol for women with unexplained infertility or those with known endometriosis to avoid poor IVF outcomes
There is some evidence that endometrial scratching biopsy may enhance embryo attachment in future cycles Vitagliano et al 2018 although not all studies agree Lensen et al 2019 The endometrial biopsy taken in the secretory phase will be tested for BCL6 and SIRT1 expression two proteins highly associated with the presence of endometriosis Yoo et al 2017 The samples of endometrium will be processed put into formalin and paraffin blocks or saved in RNA later and not be analyzed until after completion of the ART cycle Patients as well as the clinicians will be blinded to results and until the conclusion of the ART cycle following embryo transfer and subsequent pregnancy testing This will be done to avoid interfering with the current ART cycle and to avoid the introduction of bias Patients will be provided with test results after completion of the first embryo transfer if they wish to know
There is some evidence that endometrial scratching biopsy may enhance embryo attachment in future cycles Vitagliano et al 2018 although not all studies agree Lensen et al 2019 The endometrial biopsy taken in the secretory phase will be tested for BCL6 and SIRT1 expression two proteins highly associated with the presence of endometriosis Yoo et al 2017 The samples of endometrium will be processed put into formalin and paraffin blocks or saved in RNA later and not be analyzed until after completion of the ART cycle Patients as well as the clinicians will be blinded to results and until the conclusion of the ART cycle following embryo transfer and subsequent pregnancy testing This will be done to avoid interfering with the current ART cycle and to avoid the introduction of bias Patients will be provided with test results after completion of the first embryo transfer if they wish to know
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4R44HD097750-02 | NIH | None | httpsreporternihgovquickSearch4R44HD097750-02 |