A Randomized Control Trial to Investigate the Effect of Growth Hormone on the Euploid Rate of Blastocyst in Patients With Advanced Maternal Age
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- euploidy rate
研究概览
简要总结
This randomized trial aims to compare the euploid rate of blastocysts in AMA patients undergoing PGT-A (preimplantation genetic testing for aneuploidy) with or without growth hormone supplement.
Infertile patients ≥38 years old will be recruited for study after informed consent if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups:
Treatment group: Women will receive growth hormone (GH) supplement before and during antagonist protocol for ovarian stimulation.
Control group: Women will receive antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts.
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
- Single (Outcomes Assessor)
盲法说明
The embryologists, genetic scientists, and the independent statistician will be blinded to the group allocation.
入排标准
- 年龄范围
- 38 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥38; intended to undergo PGT-A
- •BMI in the normal range (18.50-24.0kg/m2)
- •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
- •History of endocrine disorder, autoimmune diseases or diagnosed thrombophilia
- •History of GH supplementation in the previous IVF treatment or taking other supplementary drugs used during stimulation; patients with absolute or relative contraindications to GH treatment, including active malignancy or history of cancer, diabetic retinopathy, diabetes mellitus, and chronic kidney disease.
研究组 & 干预措施
Treatment group
GH is supplemented during ovarian stimulation
干预措施: Growth Hormone (Drug)
Treatment group
GH is supplemented during ovarian stimulation
干预措施: GnRH antagonist (Drug)
Control group
GH is not supplemented during ovarian stimulation.
干预措施: GnRH antagonist (Drug)
结局指标
主要结局
euploidy rate
时间窗: 1 month after oocyte retrieval
euploidy rate of blastocysts
次要结局
- live birth rate(1 year after embryo transfer)
- cumulative live birth rate(1 year after embryo transfer)
- ongoing pregnancy(12 weeks' gestation)
- number of euploid blastocysts in an OS cycle(1 month after oocyte retrieval)
- clinical pregnancy rate(6 weeks after embryo transfer)
- the probability of obtaining euploid blastocysts in an OS cycle(1 month after oocyte retrieval)
- KIDScore of euploid embryos(6 days after oocyte retrieval)