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Validation of Addition of Uterine Fluid to Human Embryo Culture Medium

2018年2月12日 更新者:IVI Murcia

Infertility or infertility affects about 15% of couples of reproductive age. It is estimated that 80 million people around the world suffer from this problem. Assisted reproduction techniques (ART) use culture media (during in vitro fertilization or early embryo development) with protein sources that are very different from natural sources. This media could produce an added stress to the gametes and embryos that could cause epigenetic alterations and health effects during adult life.

Our working hypothesis is based on studies in animal models (pig and cow), in which it was observed that the culture media with reproductive fluids used as additives instead of conventional sources of proteins (such as serum albumin) , produce embryos with an epigenetic profile closer to that of embryos generated in the maternal oviduct. Moreover, with these fluids, blastocysts obtained have a greater number of cells and hatchability than those produced with serum albumin alone.

Therefore, the University of Murcia, with an extensive experience in this area, and the IVI Murcia (Valencian Infertility Institute) research team have come together to launch this research project in order to determine the advantages of the use of human reproductive fluids as additives in embryonic culture media. To do this, 2 specific objectives are proposed,:

  1. Creation of the first collection of human uterine fluid samples for Assisted Reproduction use.
  2. To evaluate the use of uterine fluid as a media supplement in the culture media for assisted reproduction techniques, by evaluating embryo quality cultured with autologous fluid from voluntary patients (autologous culture)

This achievement would allow us the development of protocols in the nearest ART physiological conditions which represent not only a technical challenge but a biomedical responsibility that must be addressed to prevent future diseases of the offspring.

研究概览

地位

未知

条件

详细说明

  1. Creation of the first collection of human uterine fluid samples for Assisted Reproduction use. Female reproductive system will be collected at the Virgen de la Arrixaca University Clinical Hospital from surgical pieces of patients undergoing surgical procedures. IVI Murcia Clinics uterine fluids from oocyte donors will be collected. These fluids will be store in the Arrixaca Hospital Biobank for future researches.
  2. Validation of the addition of uterine fluid to human embryonic culture media:

Couples undergoing assited Reproduction Treatment in IVI Murcia will be asked for their inclusion in this study. Uterine fluid will be take 48 hours after peak of LH (luteinizing hormone), in natural cycle. Oocytes from these patients, will be divided into two groups: Half of the zygotes of each patient, control group, will be grown in the conditions usually used in the clinic, and the other half, experimental group, will add 1-5% of uterine fluid from the patient (v / v)

On day 3 and on day 5 of culture the quality of the embryos in both groups will be assessed according to the usual criteria of the clinic and the best quality and highest probability of implantation will be transferred, following the usual clinical practice. The samples of uterine fluid, after the initial processing in the IVI-Murcia clinic will be transferred to the Department of Physiology of the University of Murcia where they will be fractionated to perform a quality control according to the following specifications:

Uterine fluid pH 7.0-7.6 Osmolarity (mOsm / kg) 260-320 Endotoxin (EU / mL) <0.15 Sterility No growth

Only samples that meet these criteria will continue to be part of the study

研究类型

观察性的

注册 (预期的)

27

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Murcia、西班牙、30007
        • 招聘中
        • IVI Murcia

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 39年 (成人)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

infertility couples

描述

Inclusion Criteria:

  • Couples in icsi treatment

Woman:

BMI between 17 and 30.Under controlled ovarian stimulation and at least 8 metaphase II oocytes collected

Man:

Sperm concentration higher than 5 million sperm / ml

Exclusion Criteria:

  • Woman:

Diagnosis of endometriosis Uterine pathology that compromises embryonic development Patients undergoing treatment for repeat abortion or implantation failures Abnormal karyotype Patients included in the Pre-Implantation Genetic Diagnosis (DPI) program

Male:

Men whit abnormal karyotype, High values of DNA fragmentation Abnormal FISH (Fluorescence in situ Hybridization) Sperm from epididymal aspirate or testicular biopsy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
embryo quality
大体时间:embryo quality will be analyze on day 3 and 5 after fertilization
Number of embryo with A or B quality according to ASEBIR (Spanish association for the study of the biology of reproduction) criteria
embryo quality will be analyze on day 3 and 5 after fertilization

次要结果测量

结果测量
措施说明
大体时间
Pregnancy rate
大体时间:between 14-16 days after fertilization
serum levels of chorionic gonadotropin Beta (Beta-hCG)
between 14-16 days after fertilization
ongoing pregnancy
大体时间:16-18 week after fertilization
ultrasonography
16-18 week after fertilization
implantation rate
大体时间:24 days after fertilization
number of embryos implanted/number of embryos transferred x100
24 days after fertilization
pregnancy loss rate
大体时间:10 days after B-hCG evaluation at end of pregnancy
number of miscarriages/ number of ongoing pregnancy x100
10 days after B-hCG evaluation at end of pregnancy

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Jose Landeras, MD、IVI-RMA

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月30日

初级完成 (预期的)

2019年10月30日

研究完成 (预期的)

2019年12月31日

研究注册日期

首次提交

2018年2月12日

首先提交符合 QC 标准的

2018年2月12日

首次发布 (实际的)

2018年2月19日

研究记录更新

最后更新发布 (实际的)

2018年2月19日

上次提交的符合 QC 标准的更新

2018年2月12日

最后验证

2018年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1607-MUR-055-JL

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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