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临床试验/NCT06859944
NCT06859944招募中不适用

Prospective Randomized Non-Inferiority Study Comparing Natural Cycle Frozen Embryo Transfer (NC-FET) to a New Type of Endometrial Preparation for FET: Natural Proliferative Phase (NPP-FET)

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2024年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
272
试验地点
1
主要终点
Comparison of the pregnancy rate (Human chorionic gonadotropin hormone) (HCG+ level) obtained after spontaneous embryo replacement and following the "NPP" protocol.

研究概览

简要总结

Frozen embryo replacement cycle :Two methods traditionally used: the spontaneous cycle and the artificial cycle.Now, Emergence of new protocols: NPP-FET or "Natural proliferative phase - frozen embryo transfer" Demonstrate non-inferiority between the NPP-FET and the spontaneous cycle, and superiority in terms of planning.

详细描述

The protocol Natural proliferative phase/Natural Programmed by Progesterone, Patients with regular cycles, candidates for replacement of embryos frozen in a spontaneous cycle. The monitoring of the cycle is carried out by taking blood and follicular ultrasound between the 10th and 13th day of the cycle. Support luteal phase by intravaginal progesterone (utrogestan 200 mg) 1 tablet, 2 times per day, is initiated once the following criteria are met:

  • Thickness of the endometrium > 7 mm on ultrasound
  • Ovarian follicle > 14 mm
  • Estradiol( E2) > 120 pg/mL Embryo transfer is scheduled on the 6th day of progesterone exposure exogenous. A progesterone dosage on the day of transfer will be systematically realized

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Single transfer Blastocyste

排除标准

  • •PGT (Preimplantation genetic diagnosis)
  • •Testicular Sperm
  • •Donor oocytes

结局指标

主要结局

Comparison of the pregnancy rate (Human chorionic gonadotropin hormone) (HCG+ level) obtained after spontaneous embryo replacement and following the "NPP" protocol.

时间窗: Thrugh study completion (9 months)

次要结局

未报告次要终点

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Delbaere

Professor

Erasme University Hospital

研究点 (1)

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