Infertility Clinical Trial
Official title:
The Cytokine Paired Footprint of Successful Implantation
Implantation failure of the embryo might be the result from the environment in the uterus. Proteins (cytokines) are screted by the endometrium which can result in a pro or anti inflammatory environment. The aim of this study is to identify pre-implantation endometrial and embryo cytokine expression profiles associated with successful and unsuccessful embryo implantation in assisted reproduction cycles.
Rationale:
Failure of the transferred embryo to implant remains the most important limiting factor
determining IVF success rates. It is hypothesed that implantation failure following IVF
treatment may be caused by abnormal cytokine expression by embryos and endometrium and by
subclinical bacterial vaginosis. Analysis of cytokine expression in the culture media of
embryos and in the endometrium during 'the window of implantation' offers the opportunity to
study the cross-talk between the embryo and endometrium and identify optimal cytokine
expression patterns. Increased knowledge of cytokine interaction and the impact of bacterial
vaginosis on cytokine expression may serve as the basis from which to develop and apply
treatment regimens to improve embryo selection and endometrial preparation.
Objective:
The aim of this study is to identify pre-implantation endometrial and embryo cytokine
expression profiles associated with successful and unsuccessful implantation.
Study design:
The study design is a prospective, mono-center, observational cohort study. Study
population: We will aim to include at least 160 women initiating their first or second IVF/
ICSI cycle. A subgroup of forty women will be invited for endometrial secretion aspiration
in a natural cycle as well.
Main study parameters/endpoints:
For research purposes, transcervical aspiration of endometrial secretion will be performed.
An endocervical swab will be taken to assess the existence of bacterial vaginosis. A single
ultrasound measurement of uterine artery pulsatile resistance will be made (by pulsed
Doppler) and endometrium thickness will be measured. The embryo transfer and IVF/ ICSI
treatment will be performed as usual. The main study parameter is the cytokine profile in
the endometrium and from the embryo culture medium, measured with Luminex (a multiplex
immunoassay). Implantation rate, ultrasound measurements and bacterial vaginosis will be
correlated to the cytokine profile. The cytokine profile from the endometrium will be
compared with the cytokine profile from the supernatant of the embryo. In a reference group
the cytokine profile in the endometrial secretion in a natural cycle will be compared to the
cytokine profile in a IVF/ ICSI treatment cycle.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness:
The theoretical risk associated with this study might be disruption of embryo implantation.
However, our group has developed a technique of obtaining endometrial material at the time
of embryo transfer which, as we have previously shown, does not disrupt the process of
implantation. The burden is minimal; patients will not have to make an extra visit to the
hospital. The investigations are painless and will not take more than a few minutes. No side
effects or risks have been reported.
;
Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A |