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临床试验/NCT04454749
NCT04454749终止不适用

Endometrial Compaction and Its Influence on Pregnancy Rate in Frozen Embryo Cycle Regimes

ART Fertility Clinics LLC1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Ongoing pregnancy rate

研究概览

简要总结

For a pregnancy to occur, an euploid embryo at blastocyst developmental stage, a receptive endometrium and the synchrony of both is crucial. Many studies lately investigated the influence of the endometrial thickness and pattern on the artificial reproductive technology (ART) outcome, however, with conflicting results.

详细描述

Further on, the measurement of the endometrial thickness was mostly performed either on the day of final oocyte maturation in stimulated cycles with fresh embryo transfer or on the day of progesterone administration in FET cycles.

Progesterone is essential for the secretory transformation and compaction of the endometrium, prior to implantation. A recently published paper (Haas et al., 2019) however, evaluated the degree of endometrial compaction under the influence of progesterone in FET cycles and described, that a lack of certain endometrial compaction has a negative impact on the ongoing pregnancy rate. As in this study embryos of unknown ploidy status were transferred, the role of embryo ploidy on the outcome may bias the study results.

In the herein presented study protocol we aim to investigate the influence of endometrial compaction in FET cycles in which euploid embryos are transferred.

HYPOTHESIS

Lack of endometrial compaction after the start of progesterone leads to an impaired reproductive outcome.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18 years to 40 years with regular menses (26-34 days)
  • Having 1 or 2 chromosomally normal cryopreserved blastocysts available for transfer after IVF / ICSI treatment
  • First frozen-thawed transfer cycle
  • Progesterone level < 1.5 ng/mL day of trigger injection in stimulation cycle from which embryos to be transferred were created.

排除标准

  • Polycystic ovarian syndrome
  • Poor ovarian responder in accordance with Bologna criteria
  • Uterine abnormality US / saline infusion sonohysterogram
  • Previous dilatation & curettage (D&C)
  • Hydrosalpinx
  • Asherman syndrome
  • History of endometriosis AFS ≥ 2
  • ICSI due to severe male factor with testicular sperm
  • Any known contraindications or allergy to oral estradiol or progesterone.
  • Discontinuation of HRT medication ( medication error in research HRT cycle )
  • Failure to detect ovulation in the research natural cycle
  • Ovulation after day 20 in a natural cycle
  • Duration of estradiol exposure ≥ 17 days and endometrium < 6mm
  • Spontaneous ovulation in HRT artificial cycle

结局指标

主要结局

Ongoing pregnancy rate

时间窗: 12 weeks

Ongoing pregnancy rate (≥ 12 weeks) in patients with endometrial compaction compared to patients without endometrial compaction after frozen embryo transfer of 1 or 2 euploid blastocysts

次要结局

  • Biochemical pregnancy rate in HRT cycle(5 weeks)
  • Clinical implantation rate in HRT cycle(6 weeks)
  • Biochemical pregnancy rate in spontaneous cycle(5 weeks)
  • Clinical implantation rate in spontaneous cycle(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Lawrenz

Scientific Director

ART Fertility Clinics LLC

研究点 (1)

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