Increasing the Accuracy to Predict Pregnancy Success After Assisted Reproductive Therapy (ART) by Combining the ReceptIVFIty Test with Immunological Parameters
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Immune Cell Phenotype and Function in Menstrual Blood Stratified by Vaginal Microbiome in IVF Patients
研究概览
简要总结
The goal of this clinical non-invasive observational pilot study is to improve the prediction of pregnancy success after In Vitro Fertilisation (IVF)/IVF -Intracytoplasmic Sperm Injection (ICSI) treatment by examining the vaginal microbiome and the immunological profile of menstrual blood in women (18-42) years old) undergoing their first IVF/IVF/ICSI treatment.
The main questions it aims to answer are:
What is the ReceptIVFity profile (low, medium, or high) of the vaginal microbiome in these women? How do the endometrial-derived lymphocytes respond to different immune stimuli and microbiota? Can the endometrial stromal cells decidualize effectively in the presence or absence of specific microbiota?
Participants will:
Self-perform a vaginal swab to determine the ReceptIVFity profile of their vaginal microbiome.
Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours for immunological analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Indication for an IVF or IVF/ICSI procedure.
- •18 years - 42 years.
- •European origin
- •Willing to provide a vaginal swab with the ReceptIVFity-test.
- •Willing to provide informed consent.
排除标准
- •No transferable embryos after IVF or IVF/ICSI.
- •Emergency IVF for cancer or other reasons.
- •Women with endometriosis pre-treated with an Gn-RH analogue.
- •The use of (hormonal) contraceptives or antibiotics 3 months prior to start IVF or IVF/ICSI.
- •Women unable or unwilling to agree with the procedures.
- •Women unable or unwilling to give written informed consent.
结局指标
主要结局
Immune Cell Phenotype and Function in Menstrual Blood Stratified by Vaginal Microbiome in IVF Patients
时间窗: Baseline and 3 months
Analysis of monocyte, Natural Killer (NK) cell, T lymphocytes, regulatory T lymphocytes, and T helper cell phenotypes in menstrual blood. Immune responses, including cytokine production and immune marker regulation, will be quantified. Unit of Measure: Percentage of cell type, cytokine concentrations in pg/mL.
Genotyping of Maternal KIR and HLA-C
时间窗: Baseline
Determination of maternal Killer cell immunoglobulin-like receptor (KIR) and Major Histocompatibility Complex (HLA-C) genotypes. Unit of Measure: Genotype classification.
RNA Analysis of Stromal Fibroblast Cells
时间窗: Baseline
Analysis of RNA from stromal fibroblast cells to determine expression of tissue adaptation markers (pre-decidualization). Gene expression levels (e.g., fold change, normalized counts).
次要结局
- Metabolite Analysis as Immune Signaling Modulators in IVF Patients(Baseline)
研究者
Sam Schoenmakers
Principal Investigator
Erasmus Medical Center