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临床试验/NCT03817060
NCT03817060Unknown不适用

CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage in a Single Embryo Transfer Setting (MELISSA)

Université Libre de Bruxelles0 个研究点目标入组 128 人开始时间: 2019年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
128
主要终点
Cumulative live birth

研究概览

简要总结

Ovarian stimulation for the induction of multifollicular growth by gonadotrophins represents an important part of In Vitro Fertilization (IVF). However, the use of these drugs can be associated with side effects, from which the most common is the Ovarian Hyperstimulation Syndrome (OHSS). Stimulation with gonadotrophins in a Gonadotropin-releasing hormone (GnRH) antagonist cycle rather than a GnRH agonist cycle reduces significantly the risk of OHSS. During stimulation, the best predictor of severe OHSS is the number of follicles >10mm on the day of triggering final oocyte maturation, with the threshold at ≥16 follicles. When this occurs, final oocyte maturation can be induced with a GnRH agonist, reducing further the risk the syndrome. To perform a fresh embryo transfer, 1500 IU human Chorionic Gonadotropin (hCG) can be administered on the day of oocyte retrieval for the luteal support. However, with this procedure there are still some cases of OHSS. To overcome this, it is suggested to combine GnRH agonist triggering with a freeze-all embryos strategy and perform embryo replacement in subsequent frozen-thawed embryo transfer (FET) cycles. Different cryopreservation strategies are been performed according to the procedure of each fertility center, such as cryopreservation at 2 pronuclear (2PN), cleavage or blastocyst stage. The aim of this study is to determine the optimal strategy for the freeze-all cycles and particularly the optimal day for freezing, thawing and transferring the embryos. The hypothesis is that there will increased cumulative live birth rates per started cycle in blastocyst compared to cleavage stage FET cycles.

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
None

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

  • Patients <40 years old
  • Indication for In Vitro Fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI)
  • No more than 2 previous failed IVF/ICSI cycles
  • Stimulation in GnRH antagonist cycle
  • Presence of ≥16 follicles of >10mm on the day of triggering of final oocyte maturation
  • GnRH agonist trigger (triptorelin 0.2mg)

排除标准

  • Cycles with testicular sperm extraction
  • Preimplantation genetic diagnosis
  • Patients with uterine malformations
  • Patients with infectious diseases

研究组 & 干预措施

Blastocyst

Active Comparator

Embryos cryopreserved with vitrification at the blastocyst stage (day 5 or 6)

干预措施: cryopreservation of embryos at blastocyst stage (Procedure)

Cleavage

Active Comparator

Embryos cryopreserved with vitrification at the cleavage stage (day 3) of embryo development

干预措施: cryopreservation of embryos at cleavage stage (Procedure)

结局指标

主要结局

Cumulative live birth

时间窗: within one year of randomisation

Cumulative live birth rate per oocyte retrieval

次要结局

  • Frozen thawed embryo transfer cycles needed to achieve live birth(within one year of randomisation)

研究者

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

Theoni Tarlatzi

Principal Investigator

Université Libre de Bruxelles

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