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临床试验/NCT03445923
NCT03445923终止不适用

Can Time-lapse Parameters be Used to Predict Pregnancy of Human Embryos?

Fertilitetscentrum AB11 个研究点 分布在 3 个国家目标入组 776 人开始时间: 2018年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
776
试验地点
11
主要终点
Ongoing pregnancy (week 6-7)

研究概览

简要总结

All patients starting an IVF-treatment at the clinics, and meeting the inclusion criteria, will be offered to participate in the study. Randomization will be performed on day 5 and the patients will be allocated into either morphology only group or time-lapse group. Embryos will be cultured to day five according to the clinics own routines. All embryos in both groups will be cultured using time-lapse incubation. In the control group the embryo selection will be based only on traditional morphological evaluation and in the treatment group a time-lapse selection model (KID Score day 5) will be used to select the embryo.

详细描述

The aim is to study if algorithm calculated from time-lapse photography of human embryos per se can enhance the prediction of the embryo´s reproductive potential compared to embryo morphology alone.

METHODS AND MATERIAL IVF procedure Oocytes retrieved 36±1h after hCG administration will be fertilized by either standard insemination or ICSI. The morning after oocyte retrieval (day 1) zygotes will be placed into embryo time-lapse slides for culture up to the day of transfer (day 5). During the culture time, embryos will be kept in commercially available culture media and will not be removed from the time-lapse incubator until day of transfer. Embryos interact with the media and will be allowed to develop the blastocyst stage (5-6 days culture) at which time selection for transfer will be made. During the in vitro culture a single image captured in the time-lapse incubator will be used to routinely morphologically grade embryos, according to the Istanbul consensus. On day 5, developing embryos will be assessed (according to study vs. control group criteria) to select the embryo for transfer into the patient. Supernumerous GQE will be cryopreserved for future use.

Time-lapse photography All embryos will be placed in wells of time-lapse culture dishes (Embryoscope) according to the instructions of the manufacturer. Embryos in both groups will be cultured to the blastocyst stage without any media change. The time-lapse system is comprised of a desktop incubator that controls it´s environment (pH, CO2 and O2) as well as taking pictures in up to 11 focal planes for the whole duration of the culture periods.

Morphological scoring Embryo morphology will be scored according to the Gardner score and then translated to the Istanbul consensus system if needed for publication.

To assure that all embryologists annotate the embryo development correctly as well as score the blastocysts in the same way, a validation process will be performed before the onset of the study. The standardization will be accomplished through a process where the embryologists will score 20 blastocysts at day 5-development stage, which will be provided on a CD, imitating the procedure will be performed routinely in the laboratory. The embryologists will have to be approved in order to be allowed to score embryos in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Couples undergoing IVF or ICSI (intracytoplasmic sperm injection) that do not meet the

排除标准

  • The couple shall receive and sign written information about the study.
  • On day 5, before the randomization the couple must have at least 2 transferrable blastocysts in order to be included in the study.
  • Exclusion Criteria:
  • If double embryo transfer, for any reason, is planned.
  • Prior participation in the study.
  • Pre-implantation genetic diagnosis (PGD) treatment.
  • Embryo transfer on another day than day
  • Oocyte cryopreservation.
  • Planned total freeze of embryos for any reason (cancer, OHSS etc.)

结局指标

主要结局

Ongoing pregnancy (week 6-7)

时间窗: Patient is assessed 6-7 weeks after embryo transfer

A confirmed pregnancy by ultrasound in the 6-7th week of gestation.

次要结局

  • Positive pregnancy tests, 18 days after embryo transfer.(Patient is assessed 2 weeks after embryo transfer by taking a pregancy test)
  • Correlation between the preliminary decisions of embryo fate based only on morphology and the final decision made by time-lapse(Can be made on the day of transfer (1 hour between primary and seconday decision).)
  • Early pregnancy loss (positive pregnancy test but no gestational sac observed at sonography)(Same time frame as for the primary outcome i.e. 6-7 weeks.)

研究者

发起方
Fertilitetscentrum AB
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thorir Hardarson

Laboratory Director

Fertilitetscentrum AB

研究点 (11)

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