To Explore the Effect of Low-dose Long Term Growth Hormone Pretreatment on Clinical Pregnancy Outcomes in Patients With Low Ovarian Reserve
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 114
- 主要终点
- rate of good quality embryos
研究概览
简要总结
Growth hormone (GH) has been used in the field of assisted reproduction technology for over 30 years. Studies for GH have been exploring in the applicable population, drug dosage, starting time and time limitation. In previous clinical applications, it worked as an adjuvant drug for improving ovarian reactivity. With the development of basic research and clinical applications, the improvement effect on egg quality is gradually recognized. However, which protocol of GH may work well and maximize the clinical effect remains mystery. The investigators' previous self-controlled retrospective research about 380 cases treated with GH found that the average daily injection of GH dose of 2IU for about 6 weeks can significantly improve embryo quality and clinical pregnancy outcomes of the patients with low ovarian response. The new POSEIDON standard clearly groups people with low prognosis and better classifies heterogeneous people, which may help classifying the specific subgroup that benefit most from GH of poor ovarian response (POR). The investigators design a prospective cohort study to explore whether GH low-dose long-term pretreatment can improve the outcome of assisted pregnancy and its possible mechanism in people with low ovarian reserve.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •low ovarian reserve(AMH <1.2ng/ml, or AFC <5);
- •patients who have not participated in any clinical trials within the three months;
- •patients who voluntarily signed informed consent.
排除标准
- •patients with BMI ≥30kg/m2;
- •patients with medical diseases such as endocrine and metabolic diseases, autoimmune disease, etc;
- •ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery;
- •complicated with adenomyosis, endometriosis confirmed by surgery;
- •patients with untreated abnormal intrauterine environment, such as uterine effusion, endometritis, etc;
- •untreated hydrosalpinx.
研究组 & 干预措施
GH group
GH group: Participants diagnosed POR according to POSEIDON criteria with low ovarian reserve undergo IVF in our center with long protocol or antagonist protocol and is adjuvant with GH 2IU/d from previous menstrual period for about six weeks.
干预措施: growth hormone (Drug)
结局指标
主要结局
rate of good quality embryos
时间窗: 2 years
the number of good quality embryos divide by the number of transferrable embryos
次要结局
- fertilization rate(2 years)
- live birth rate(2 years)
- number of oocytes retrieved(2 years)
- clinical pregnancy rate(2 years)