Infertility Clinical Trial
Official title:
Recurrent Embryo Implantation Failure in Women Undergoing IVF/ ICSI; an Investigation of the Intra-Uterine Environment During the Window of Implantation
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.
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 parameters/endpoints:
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.
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