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临床试验/NCT04458454
NCT04458454已完成不适用

"Study of the Effects of Serum and Follicular Fluid Relaxin Levels on Ovarian Function in IVF Cycles as a Part of the Project "Relaxifert" "

D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2019年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
1
主要终点
Correlation between the relaxin values in follicular fluid and the number of oocytes obtained

研究概览

简要总结

The study evaluated the effect of serum relaxin and follicular fluid levels on the number and quality of oocytes, fertilization, the number and quality of the embryos in IVF protocols.

详细描述

Relaxin is one of the promising indicators of oocyte quality and prognosis of the effectiveness of invitro fertilization protocols. The hormone plays an important role in the processes of folliculogenesis, growth and maturation of oocytes, development of embryos, implantation processes, pregnancy and childbirth. A pilot study was conducted on a group of patients undergoing infertility treatment using assisted reproductive technologies in the superovulation stimulation protocol using gonadotropin releasing hormone antagonists. Blood and follicular fluid samples were obtained on the day of transvaginal follicular puncture. The results allow us to consider the hormone relaxin as a promising predictor of the result of ovarian stimulation, the effectiveness of fertilization in IVF cycles.

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
20 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of Primary or Secondary infertility
  • Must be signed the voluntary informed consent to participate in the study.

排除标准

  • The presence of IVF contra-indications.
  • Clinical diagnosis of large uterine fibroids.
  • BMI> 35 kg / m2
  • Morphological diagnosis of endometrial hyperplastic processes
  • Clinical diagnosis of infectious.
  • Clinical diagnosis of systemic autoimmune diseases.
  • Insulin dependent diabetes
  • Oncological diseases

结局指标

主要结局

Correlation between the relaxin values in follicular fluid and the number of oocytes obtained

时间窗: 10-14 days from the start of stimulation in the IVF protocol ( the day of transvaginal follicular puncture)

The level of relaxin in follicular fluid was estimated using an ELISA Kit for Relaxin 2. The range of detectable concentrations was 3.1-500 pg / ml. Higher relaxin concentrations in follicular fluid are associated with a higher number of oocytes obtained.

次要结局

  • Correlation between the relaxin levels in follicular fluid and oocyte fertilization efficiency(10-14 days from the start of stimulation in the IVF protocol for relaxin. The first day after transvaginal follicular puncture for evaluation oocyte fertilization efficiency.)
  • Correlation between the relaxin levels in follicular fluid and age(10-14 days from the start of stimulation in the IVF protocol)
  • Correlation between the relaxin levels in follicular fluid and BMI(10-14 days from the start of stimulation in the IVF protocol)

研究者

发起方
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olesya Nikolaevna Bespalova

Olesya Nikolaevna Bespalova, MD, PhD, DSci (Medicine), Deputy Director for Research. The Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott

D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology

研究点 (1)

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