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临床试验/NCT04733235
NCT04733235已完成不适用

The Effect of Progesterone Induced Endometrial Compaction on Pregnancy Outcomes in Frozen-thawed Embryo Transfer at the Blastocyst Stage

Akdeniz University1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
205
试验地点
1
主要终点
ongoing pregnancy rates.

研究概览

简要总结

The purpose of this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

详细描述

For a pregnancy to occur, the embryo must implant in a receptive endometrium during the window of implantation, which is thought to occur from day 22 to 24 of an idealized 28-day cycle. Early studies have suggested that assessing endometrial thickness with the use of ultrasound may be an alternative to invasive techniques such as endometrial biopsy for attempting to determine a receptive endometrium for frozen-thawed embryo transfer (FET).

A preovulatory endometrial thickness of 7 mm or more is considered to be the cutoff for endometrial receptivity, below which many physicians would cancel an embryo transfer. However, in most studies in the literature, endometrial thickness was measured either on the day of hCG in fresh embryo transfer cases or on the last day of estrogen treatment in thawed embryo transfers. There are a limited number of studies evaluating the luteal period, embryo transfer day and endometrial thickness.

Accordingly, in this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

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

  • Woman aged 18-40 years
  • Presence of high quality (>2BB) blastocyst
  • Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
  • presence of high quality blastocyst cryopreserved by vitrification method.
  • A single embryo transfer

排除标准

  • Presence of uterine pathology
  • Participants whose optimal endometrial image cannot be obtained due to uterine position
  • Participants whose treatments were canceled for any reason before embryo transfer
  • Participants which had embryo transfer on the day 2 or 3 (at the cleavage stage)
  • Participants who had 2 embryo transfer
  • Presence of low quality (<2BB) blastocyst
  • > 15% loss of viability in the embryo during embryo thawing

研究组 & 干预措施

with endometrial compaction

Participants who have endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement

干预措施: Progesterone (Drug)

without endometrial compaction

Participants who have not endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement

干预措施: Progesterone (Drug)

结局指标

主要结局

ongoing pregnancy rates.

时间窗: 1 year

pregnancy beyond 12 weeks of gestational age.

The change in endometrial thickness

时间窗: 1 year

changing in millimeters of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.

次要结局

  • Clinical pregnancy rate(6-7 weeks after the last menstrual period of the patient)
  • The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer(On the day of frozen embryo transfer)
  • Clinical miscarriage(after 5th gestational week)
  • Implantation rate(5 weeks after the last menstrual period of the patient)

研究者

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

ŞAFAK OLGAN

ASSOCIATE PROFESSOR

Akdeniz University

研究点 (1)

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