跳至主要内容
临床试验/NCT06103383
NCT06103383招募中不适用

Second Phase of the Pilot Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women

Instituto Valenciano de Infertilidad, IVI VALENCIA1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年2月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
Oocyte in-vitro maturation

研究概览

简要总结

In vitro maturation (IVM) is a technique for obtaining potentially fertilizable oocytes from immature oocytes. An oocyte must be mature both nuclearly and cytoplasmically in order to be competent in the reproductive process. Nuclear maturation involves an oocyte in metaphase II stage and is easily evaluated for its morphology. However, cytoplasmic maturation can only be evaluated by in vitro fertilization of that oocyte. A mature nuclear and cytoplasmic oocyte is the one capable of producing a viable embryo. This study aims to optimize the in vitro maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried out to check the cytoplasmic maturation of the oocytes, avoiding the generation of potentially viable embryos.

This study corresponds to a second phase of the pilot study for the development of this technique in our IVF laboratory. We will use all we have learned in the first phase, as well as the experience acquired, to advance in the optimization of this protocol.

The correct functioning of this IVM technique would mean a reduction in the costs of ovarian stimulation treatments, as lower doses and shorter stimulation times are required, which implies lower risks for women derived from the medication and less stress for them.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Donors with history of optimal ovarian response

Experimental

IVIRMA Valencia donors between the ages of 18-35 years old, with normal ovarian function, with a history of optimal ovarian response (at least 10 total oocytes and/or 8 MII) and who have already completed all their donation cycles allowed by law.

干预措施: Controlled ovarian stimuation (Drug)

Donors with history of optimal ovarian response

Experimental

IVIRMA Valencia donors between the ages of 18-35 years old, with normal ovarian function, with a history of optimal ovarian response (at least 10 total oocytes and/or 8 MII) and who have already completed all their donation cycles allowed by law.

干预措施: Oocyte pick up (Procedure)

Donors with history of optimal ovarian response

Experimental

IVIRMA Valencia donors between the ages of 18-35 years old, with normal ovarian function, with a history of optimal ovarian response (at least 10 total oocytes and/or 8 MII) and who have already completed all their donation cycles allowed by law.

干预措施: Oocyte in vitro maturation (Procedure)

Donors with history of optimal ovarian response

Experimental

IVIRMA Valencia donors between the ages of 18-35 years old, with normal ovarian function, with a history of optimal ovarian response (at least 10 total oocytes and/or 8 MII) and who have already completed all their donation cycles allowed by law.

干预措施: Oocyte in vitro activation (Procedure)

结局指标

主要结局

Oocyte in-vitro maturation

时间窗: 1 YEAR

To evaluate the rate of potentially competent oocytes (after the in vitro maturation).

Oocyte activation

时间窗: 1 YEAR

To evaluate the rate of potentially competent oocytes after oocyte activation process.

次要结局

  • Oocyte recovery rate(1 year)
  • In vitro nuclear maturation rate(1 year)
  • Artificial oocyte activation rate.(1 year)

研究者

发起方
Instituto Valenciano de Infertilidad, IVI VALENCIA
申办方类型
Other
责任方
Sponsor

研究点 (1)

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