Preimplantation Factor (PIF): Prognostic Value of a Non-invasive Embryo Viability Biomarker Detection in Culture Media Followed by Single Embryo Transfer - Correlation With Live Birth.
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Detection of PIF in early pregnancy maternal serum
研究概览
简要总结
PIF: biomarker of successful implantation To overcome the poor reproductive potential of embryos generated during in vitro fertilization cycles and the lack of markers enabling the identification of the most competent ones, it is common to transfer multiple embryos. However this practice is associated with the risks of multi-fetal pregnancies and high morbidity/mortality. Ideally, the availability of a marker specifically produced by viable embryos would permit the transfer of a single embryo (SET) without affecting the chances of pregnancy and, most importantly, capable to drastically reduce multiple pregnancies after IVF. In preliminary work, we demonstrated that no pregnancy resulted following the transfer of embryos where PIF was undetectable in culture media.(Keramitsoglou, T et al. ASRI Meeting, Hamburg, 2012) Using a non-invasive method of detection of PIF in the media surrounding the embryo will be correlated to live birth following single embryo transfer. By selecting only viable embryos, it will reduce the need for multiple IVF cycles, increase the rate of pregnancy outcome associated with SET, and will minimize multi-fetal pregnancy that has very high medical and societal costs both in pregnancy and after delivery.
详细描述
The aim of the proposed project is to investigate a non invasive biomarker, PIF (PreImplantation Factor), a 15amino acid peptide (MVRIKPGSANKPSDD) secreted only by viable embryos and placenta (Stamakin et al. RBE 2011).
PIF positive embryos will be able to grow to blastocyst stage and PIF levels could be a marker of progressive pregnancy. We will measure PIF levels in IVF culture media before embryo transfer to correlate IVF pregnancy with PIF levels. Our objective will be to define PIF as a biomarker for viable embryos in order to increase IVF success rates following SET. PIF levels will be retrospectively evaluated after 500 SET.
Our four reproductive centres perform about 200 SET per year and more than 500 in vitro fertilizations.
For women selected for a SET, PIF levels will be evaluated in all embryo culture media, and later at one and two weeks after each transfer of fresh or thawed frozen embryos in maternal serum. Embryo transfers will be done blinded to PIF results. SET or MET will be based on clinical evaluation and conventional embryo criteria. For these women, PIF will be also evaluated and compared with βhCG level on maternal serum.
PIF assessment will be performed using specific antibody marked with a fluorescent dye, in Luminex reader.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Detection of PIF in early pregnancy maternal serum
时间窗: end of pregnancy
Following PIF positive single embryo transfer, patients' pregnancy will be monitored by standard methods. This includes: blood tests and ultrasound until pregnancy viability has been established. The number of patients that fail to implant or end up in implantation failure (ie chemical pregnancy), miscarriage, gestational sac will be recorded.
次要结局
- Correlation between PIF positive and negative embryos and early pregnancy events(end of pregnancy)
- Correlation between PIF positive and negative embryos and late pregnancy events(end of pregnancy)