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临床试验/NCT05574894
NCT05574894已完成3 期

Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study

ShangHai Ji Ai Genetics & IVF Institute1 个研究点 分布在 1 个国家目标入组 692 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
692
试验地点
1
主要终点
Proportion of cycles which obtained euploid blastocysts

研究概览

简要总结

This retrospective cohort study aims to investigate the effects of recombinant human growth hormone (rh-GH) on the euploid status of preimplantation blastocysts in AMA patients.

Infertile patients aged 38-46 years old were recruited for study if they fulfill the inclusion criteria and do not have the exclusion criteria.

Treatment group: Women received growth hormone (GH) supplement during antagonist protocol for ovarian stimulation.

Control group: Women received antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts per stimulation cycle and per testing cycle.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
38 Years 至 46 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 38-46; BMI 18.5-24.0kg/m2; intended to undergo PGT-A; GnRH Antagonist protocol for ovarian stimulation; normal semen analysis for the male partner

排除标准

  • Endometriosis grade 3 or higher, untreat hydrosalpinx;
  • Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex);
  • Untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)
  • Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease;
  • Women who received other supplement drugs during ovarian stimulation

研究组 & 干预措施

GH group

Experimental

Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

干预措施: Growth hormone (Drug)

GH group

Experimental

Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

干预措施: GnRH antagonist (Drug)

Control group

Active Comparator

No Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

干预措施: GnRH antagonist (Drug)

结局指标

主要结局

Proportion of cycles which obtained euploid blastocysts

时间窗: 1 month after oocyte retrieval

Number of cycles with at least 1 euploid blastocyst divided by the total number of stimulation cycles in a cohort

次要结局

  • Euploidy rate per cycle(1 month after oocyte retrieval)
  • Euploid blastocyst rate per cohort(1 month after oocyte retrieval)

研究者

发起方
ShangHai Ji Ai Genetics & IVF Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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