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临床试验/NCT05960370
NCT05960370招募中不适用

Impact of Endometrial Compaction on Reproductive Outcomes After Cryotransfer of Euploid Embryos in a Natural Cycle: Prospective Cohort Study

Instituto Bernabeu1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2022年6月15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
206
试验地点
1
主要终点
Ongoing pregnancy rate

研究概览

简要总结

Multicenter prospective observational cohort study, comparing ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of the transfer versus those who have a stable or greater endometrial thickness with respect to the estrogenic phase.

详细描述

Multicenter prospective observational cohort study. Based on our sample size calculation, the study group will consist of 206 women (exposed or "compaction" group: 103 women with a decrease of ≥ 5% in endometrial thickness between the estrogenic phase and the day of embryo transfer; non-exposed "non-compaction" group: 103 women with similar or greater endometrial thickness between these time points). The main objective of this study is to compare the ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of transfer versus those who with a stable or greater endometrial thickness with respect to the estrogenic phase. The estimated duration of the study is 24-30 months. Inclusion criteria are: 18 to 50 years of age, with primary or secondary infertility, subjected to endometrial preparation in a modified natural cycle for transfer of a genetically euploid blastocyst, from their own oocyte or oocyte donation, with a normal uterine cavity. Exclusion criteria are: uterine or endometrial disease (e.g., multiple myomatosis, severe adenomyosis, Asherman syndrome, refractory endometrium), conditions that prevent correct ultrasound assessment (tilted uterus), or a history of recurrent implantation failure or repeated miscarriages.

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
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged 18 to 50 years
  • Primary or secondary infertility
  • Normal uterine cavity
  • Endometrial preparation in a modified natural cycle for single embryo transfer
  • Embryo in blastocyst state from own oocyte or oocyte donation cycles, who had normal results on preimplantation genetic testing for aneuploidy (PGT-A) via trophectoderm biopsy.

排除标准

  • Uterine or endometrial disease (multiple myomatosis [>3 fibroids of > 3 cm], adenomyosis, Asherman syndrome)
  • Difficulties in correctly measuring endometrial thickness due to a retroverted or tilted uterus
  • History of recurrent implantation failure (3 or more transferred blastocysts of good quality, from their own oocyte [<35 years] or oocyte donation); recurrent early Pregnancy Loss (the loss of two or more pregnancies before 10 weeks of gestational age.
  • Suboptimal endometrial response (endometrium < 6 mm on the day of ovulation triggering).

结局指标

主要结局

Ongoing pregnancy rate

时间窗: 8-10 weeks gestational age.

Presence of an intrauterine pregnancy with positive embryo heartbeat as seen by sonography at 8-10 weeks gestational age.

次要结局

  • Ectopic pregnancy(5-8 weeks gestational age.)
  • Biochemical pregnancy loss(9-10 days after the embryo transfer.)
  • Early pregnancy loss(5-10 weeks gestational age.)
  • Clinical pregnancy(5-6 weeks gestational age.)

研究者

发起方
Instituto Bernabeu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Esperanza de la Torre Perez

Gynecologist

Instituto Bernabeu

研究点 (1)

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