A Prospective, Randomized, Controlled, Two-arm Study to Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates Through a Care Personalization in Reproductive Medicine Before IVF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis
研究概览
简要总结
A prospective, randomized, controlled, open two-arm study to evaluate the interest of the pre-conceptional endometrial immune profiling to increase birth rates.
详细描述
Birth rates following an embryo transfer with a mean of two embryos transferred stagnate around 23% per transfer (annual report of the Agency of Biomedicine). Some estimates that half of infertile patients treated are partially or totally concerned by problem of inadequate uterine receptivity.
The investigators' hypothesis is that a pre-conceptional immune endometrial evaluation may increase significantly birth rates since successful implantation results from both the matching of a competent embryo within a competent endometrium.
The identification of endometrial biomarkers documenting the immune uterine environment during the implantation window would be able to improve the efficacy of ART through a personalization of treatment accordingly to the ability of the patients to receive their embryos. All patients with all inclusion criteria and no exclusion criteria will be included. Only patients with a deregulation (immune analysis) will be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile patients will be included at the beginning of their medical care in reproduction once the indication to perform either an IVF with or without ICSI has been established. The indication for IVF will be: tubal infertility, endometriosis, ovarian dysovulation with failure of intra-uterine insemination, idiopathic infertility The indication for ICSI will be: male infertility (oligo-astheno-teratospermia), previous failure of oocytes fertilization in IVF
- •Patients should be younger than 38 years old (Age < 38)
- •with a normal ovarian reserve (AMH>1.5ng/ml, FSH<10 IU/l on day-3, antral follicles count (AFC) over 6 on day-3 of the cycle by ultrasound)
- •The range of the IVF or ICSI attempt should be lower than 3 or equal at 2 (first or second IVF/ICSI). If a live birth occurred in the past by IVF/ICSI, the range of the new attempt is
- •With a signed informed and consent form
- •With medical insurance
排除标准
- •Azoospermia or cryptozoospermia (Patient's partner)
- •IVF/ICSI attempt scheduled in another ART unit
- •Contraindication to any experimental treatment (Cortancyl, Intralipids, Human Chorionic Gonadotropin)
- •Maternal serology positive for hepatite C or B
研究组 & 干预措施
standard care
No specific treatment (standard care)
干预措施: standard care (Other)
specific treatment
As a deregulation has been diagnosed by immune analysis, a personalization of the medical care for this IVF/ICSI attempt will be dispensed Personalization of treatment should follow a step-to step decision tree.
干预措施: specific treatment (Drug)
结局指标
主要结局
Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis
时间窗: up to 18 months
Live birth rate/transfer
次要结局
- Number of prematurity (A birth below 37 weeks of amenorrhea defines the premature birth and before 28 weeks of amenorrhea the severe preterm birth) (for babies without congenital anormality or malformation)(between 28 and 37 amenorrhea weeks)
- Number of embryo implanted/number of embryos replaced)(at 8, 12 and 40 amenorrhea weeks)
- Ongoing pregnancy rate/transfer following the first embryo transfer at 12 weeks of amenorrhea(12 amenorrhea weeks)
- Number of physiological pregnancies after personalization(up to 18 months)
- Pregnancy rate/transfer following the first embryo transfer(8 amenorrhea weeks)
- Number of late miscarriage(between 13 and 24 amenorrhea weeks)
- Weight at birth(up to 18 months)
- Number of pathologic pregnancy included stillbirth and congenital abnormality(up to 18 months)
- Number of early miscarriage in the first trimester(12 amenorrhea weeks)
- Term of birth (for babies without congenital anormality or malformation)(up to 18 months)
- Number of pre-eclampsia (defined as the association of hypertension over 14/9 mm of hg with proteinuria occuring during the pregnancy- this pathology is related to insufiscient invasion during the first trimester)(up to 18 months)
- Investigate if immunologic events studying on endometrial level have an impact on blood level or are independent.(up to 15 months)