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临床试验/NCT05372549
NCT05372549已完成不适用

Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation

Clinique Ovo6 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2022年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
179
试验地点
6
主要终点
Evaluate the correlation between the oxidative stress and the quality of oocytes

研究概览

简要总结

Whether it is for oncology or personal reasons, fertility preservation allows participants to preserve their oocytes (eggs) at their current age and condition for a better chance of having a baby in the future.

In order to proceed with fertility preservation, participants will need to undergo in vitro fertilization (IVF), which is standard practice, and take stimulation medication to stimulate production of more follicles.

The combination of both Rekovelle and Menopur for fertility preservation may increase ovarian response to stimulation and increase the number of oocytes retrieved to give better chances of embryos once the oocytes will be fertilized.

The goal in this study is to understand the effect of oxydative stress on the quality of oocytes.

For the purpose of the study and to evaluate this connection, serum levels of oxidative stress and cf-DNA in your blood will be measured.

Oocyte quality will also be assessed with Magenta, a prediction tool utilizing artificial intelligence (AI). This method is non-invasive and has no risks on the oocytes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • - Women 18 to 37 years of age inclusively eligible for fertility preservation for either social or oncology reason

排除标准

  • Pregnancy and lactation
  • Uncontrolled thyroid or adrenal dysfunction
  • Tumours of the hypothalamus or pituitary gland
  • Ovarian enlargement not due to polycystic ovarian syndrome
  • Gynaecological haemorrhages of unknown aetiology
  • Endometriosis stage III/IV
  • Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle
  • Use of Coenzyme Q10 during the stimulation cycle
  • Renal and/or hepatic impairment
  • Hypersensitivity to any active ingredient or excipients in follitropin delta and/or HP-hMG

研究组 & 干预措施

Oncology preservation

Other

干预措施: Oxidative stress (Other)

Oncology preservation

Other

干预措施: cf-DNA (Other)

Oncology preservation

Other

干预措施: MAGENTA AI (Other)

Social (elective) preservation

Other

干预措施: Oxidative stress (Other)

Social (elective) preservation

Other

干预措施: cf-DNA (Other)

Social (elective) preservation

Other

干预措施: MAGENTA AI (Other)

结局指标

主要结局

Evaluate the correlation between the oxidative stress and the quality of oocytes

时间窗: Change from baseline oxidative stress at the end of IVF controlled ovarian stimulaition

Serum sample measure variations of oxidation-reduction potential (ORP) with MiOXSYS analyzer and by PCR

次要结局

  • Evaluation of oocyte quality by visualization(At the end of IVF stimulation)
  • Number of mature oocytes retrieved(IVF stimulation cycle)
  • Assessment of good quality oocytes(IVF stimulation cycle)

研究者

发起方
Clinique Ovo
申办方类型
Industry
责任方
Sponsor

研究点 (6)

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