Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351481
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2006-07-12
Brief Title:
Failure of Implantation After Recurrent Embryo Transfers
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Recurrent Embryo Implantation Failure in Women Undergoing IVF ICSI an Investigation of the Intra-Uterine Environment During the Window of Implantation
Status:
COMPLETED
Status Verified Date:
2007-04
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:
We will investigate maternal and embryonic factors in women with recurrent implantation failure undergoing IVF ICSI treatment Women who have not achieved a pregnancy after three embryo transfer procedures will undergo an endometrial biopsy during the window of implantation in a natural cycle During the next treatment cycle we will aspirate endometrial secretion and perform a doppler ultrasound investigation of the a uterina Moreover we will investigate the cytokine expression from the transferred embryo from the culture medium
Detailed Description:
Rationale
Despite advances in IVF procedures and the transfer of embryos of high morphological quality embryos pregnancy rates from IVF remain around 30 per embryo transfer procedure Failure of the transferred embryo to implant remains the most important limiting factor determining in vitro fertilization IVF or intra cytoplasmic sperm injection ICSI success rates If progress is to be made in improving implantation rates a greater understanding of the factors which determine successful implantation is required Recurrent implantation failure after IVF may be due to an endometrial and embryo problem or both All women entering our IVF program undergo pre-conceptional counseling and a pre-treatment blood withdrawal for hormonal investigation and investigation of uterine cavity by ultrasound examination hysteroscopy and endometrial biopsy The data generated by this pre-treatment screening potentially enables factors predictive of implantation failure to be identified In addition study of the further IVF cycle will increase our knowledge of the factors of endometrial and embryo factors involved in implantation failure and aid in the characterization of the different causes of this distressing clinical problem On the basis of these data rational interventions designed to improve outcome can be designed and tested
Objective
To delineate pre-treatment predictors of recurrent implantation failure to characterize the different phenotypes of women suffering from this problem and to study the relative importance of maternal and embryonic causes of implantation failure
Study design
Prospective controlled cohort study
Study population
50 women who have received at least 3 embryo transfers in previous IVF cycles carried out within the UMC Utrecht without achieving a clinical pregnancy The control group of normal implanters consists of 30 women who have previously readily conceived following ICSI for the treatment of severe male subfertility
Main study parametersendpoints
1 Retrospective analysis of screening parameters including analysis of endometrial biopsy material for Noyes criteria of endometrial dating uterine natural killer uNK cell count and dietary lifestyle parameters obtained by questionnaire during pre-conceptional counseling
2 Analysis of uNK cell count obtained from luteal phase endometrial biopsy prior to the treatment cycle
3 Analysis of endometrial secretion and embryo culture medium cytokine expression profile measured at the time of embryo transfer in a subsequent IVF cycle comparison with normal profile identified in the ICE study
Nature and extent of the burden and risks associated with participation benefit and group relatedness
Much of the data to be analysed will be collected from routine clinical work up pre-conceptional screening Women with recurrent implantation failure then embarking on a further IVF cycle will be invited to participate in this study and will undergo additional investigation This will include an endometrial biopsy prior to the treatment cycle and endometrial fluid aspiration prior to embryo transfer in the subsequent treatment cycle No negative effect on pregnancy rates from these interventions have been reported The theoretical risk associated with the aspiration of endometrial secretion before embryo transfer might be disruption of embryo implantation However our group has developed a technique which as we have previously shown does not disrupt the process of implantation
Despite advances in IVF procedures and the transfer of embryos of high morphological quality embryos pregnancy rates from IVF remain around 30 per embryo transfer procedure Failure of the transferred embryo to implant remains the most important limiting factor determining in vitro fertilization IVF or intra cytoplasmic sperm injection ICSI success rates If progress is to be made in improving implantation rates a greater understanding of the factors which determine successful implantation is required Recurrent implantation failure after IVF may be due to an endometrial and embryo problem or both All women entering our IVF program undergo pre-conceptional counseling and a pre-treatment blood withdrawal for hormonal investigation and investigation of uterine cavity by ultrasound examination hysteroscopy and endometrial biopsy The data generated by this pre-treatment screening potentially enables factors predictive of implantation failure to be identified In addition study of the further IVF cycle will increase our knowledge of the factors of endometrial and embryo factors involved in implantation failure and aid in the characterization of the different causes of this distressing clinical problem On the basis of these data rational interventions designed to improve outcome can be designed and tested
Objective
To delineate pre-treatment predictors of recurrent implantation failure to characterize the different phenotypes of women suffering from this problem and to study the relative importance of maternal and embryonic causes of implantation failure
Study design
Prospective controlled cohort study
Study population
50 women who have received at least 3 embryo transfers in previous IVF cycles carried out within the UMC Utrecht without achieving a clinical pregnancy The control group of normal implanters consists of 30 women who have previously readily conceived following ICSI for the treatment of severe male subfertility
Main study parametersendpoints
1 Retrospective analysis of screening parameters including analysis of endometrial biopsy material for Noyes criteria of endometrial dating uterine natural killer uNK cell count and dietary lifestyle parameters obtained by questionnaire during pre-conceptional counseling
2 Analysis of uNK cell count obtained from luteal phase endometrial biopsy prior to the treatment cycle
3 Analysis of endometrial secretion and embryo culture medium cytokine expression profile measured at the time of embryo transfer in a subsequent IVF cycle comparison with normal profile identified in the ICE study
Nature and extent of the burden and risks associated with participation benefit and group relatedness
Much of the data to be analysed will be collected from routine clinical work up pre-conceptional screening Women with recurrent implantation failure then embarking on a further IVF cycle will be invited to participate in this study and will undergo additional investigation This will include an endometrial biopsy prior to the treatment cycle and endometrial fluid aspiration prior to embryo transfer in the subsequent treatment cycle No negative effect on pregnancy rates from these interventions have been reported The theoretical risk associated with the aspiration of endometrial secretion before embryo transfer might be disruption of embryo implantation However our group has developed a technique which as we have previously shown does not disrupt the process of implantation
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