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临床试验/NCT05474833
NCT05474833招募中不适用

Effect of Embryo Viability and Re-expansion After Thawing in Blastocyst Stage Embryos on Pregnancy Outcomes: Prospective Cohort Study

Akdeniz University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

In this prospective study, the possible effects of embryo viability and degree of blastocele re-expansion on pregnancy outcomes before vitrified/thawed blastocyst transfer will be evaluated.

详细描述

Thanks to the advances in embryo vitrification technologies in recent years, high embryo viability can be achieved after thawing, and live birth rates increase after the transfer of these embryos.

Embryo morphology is an essential criterion used to predict embryo viability. Blastocysts endure several morphological challenges during vitrification and thawing, including blastocele collapse, cell collapse, and subsequent rehydration. Blastocysts usually collapse immediately after thawing. Because of these morphological changes, cell damage and loss may occur, and morphological integrity may be impaired.

Considering that implantation results may be affected due to supraphysiological high estrogen and progesterone levels due to multi follicular development in the ovaries during fresh embryo transfers, the study is planned to be conducted only in patients who have undergone artificial endometrial preparation with hormone replacement therapy. Only embryos frozen at the blastocyst stage (day 5) will be included in the study.

After embryo thawing, an experienced embryologist will evaluate embryo viability and expansion and record it in the system. Approximately 2 hours after the indicated procedure (just before embryo transfer), embryo viability and degree of re-expansion will be re-evaluated by the 2nd experienced Embryologist. The evaluation results of both embryologists (embryo viability and re-expansion streams) will be known only to the primary clinician (Assoc. Prof. Şafak Olgan). Pregnancy results will be learned nine days after embryo transfer, In ultrasonography evaluation three weeks after a positive pregnancy result, a clinical pregnancy will be considered in patients with fetal heartbeat, and morphological differences between the pregnant and non-pregnant groups will be evaluated.

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 18-40 years
  • Frozen- thawed embryo transfer cycles
  • Only the cycles prepared artificially with hormone replacement therapy.
  • Embryos with Day 5 (1CC and higher quality)

排除标准

  • Embryos at the cleavage stage (D3)
  • Patients for whom embryo viability and expansion were not evaluated single-blindly by two different embryologists

结局指标

主要结局

Clinical pregnancy rate

时间窗: Three weeks after each positive pregnancy test result

In ultrasonography evaluation three weeks after a positive pregnancy result, a clinical pregnancy will be considered in patients with a fetal heartbeat.

次要结局

  • Positive β-hCG results(Nine days after each embryo transfer)
  • The effect of re-expansion degrees and viability of embryos on pregnancy(Three weeks after each positive pregnancy test result)
  • Optimal time between two assessments of expansion(About 2 hours between thawing and transfer)

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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