Viewing Study NCT04549909



Ignite Creation Date: 2024-05-06 @ 3:11 PM
Last Modification Date: 2024-10-26 @ 1:44 PM
Study NCT ID: NCT04549909
Status: COMPLETED
Last Update Posted: 2020-09-23
First Post: 2020-09-09

Brief Title: Biochemical Pregnancy Loss A Multicenter Retrospective Study
Sponsor: IVI Vigo
Organization: IVI Vigo

Study Overview

Official Title: Is Biochemical Pregnancy Loss Associated to Embryo or Endometrium A Multicenter Retrospective Study
Status: COMPLETED
Status Verified Date: 2020-09
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: BPL
Brief Summary: Biochemical pregnancy loss BPL is a very frequent issue in human reproduction After the implantation of the embryo hCG disappears very soon from the maternal bloodstream and no evidence of a clinical pregnancy is seen Different studies showed that factors such as age oocyte and embryo quality and endometrium receptivity may have something to do with the occurrence of biochemical pregnancy loss post assisted reproduction treatment

The main aim of this study is to evaluate the incidence of biochemical pregnancy loss BPL in three different cohort populations patients undergoing frozen embryo transfer FET from own oocytes after preimplantation genetic testing for aneuploidy PGT-A patients undergoing FET from own and donated oocytes and with endometrial receptivity array ERA and patients undergoing FET from own or donated oocytes without PGTA or ERA test

We will analyse the incidence of BPL in these populations and try to determine the role of the euploid status embryo in the first group the endometrium in the second group and the third one as control group We are waiting to find the value of both players in the origin of BPL
Detailed Description: Human embryo implantation is a poorly understood process Once the embryo implants in the endometrium it starts to secrete hCG that can be measured in the maternal blood as early as 9 days after implantation Only a minimal number of pregnancies get to newborn and the majority are lost before reach the first trimester Larsen et al 2013

We are looking for the role of the embryo after controlling its chromosomal ploidy and the endometrium after controlling its transcriptomic expression We will also use a no exposed group to the controlled euploid embryo factor neither endometrial factor that is the oocyte donation group This analysis expects to provide more information about the key role of embryo or endometrium in BPL

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