NCT06754332尚未招募1 期
The Research on the Role of Human Chorionic Gonadotropin (HCG) Activation in Vivo on the Dormant Follicles in Patients With Premature Ovarian Insufficiency (POI).
The Fourth Affiliated Hospital of Zhejiang University School of Medicine0 个研究点目标入组 60 人开始时间: 2025年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- focilles
研究概览
简要总结
This project aims to activate dormant follicles in patients with premature ovarian insufficiency by injecting human chorionic gonadotropin (hCG) to explore the feasibility of a treatment plan that stimulates the growth of dormant follicles, not visible to the naked eye, to antral follicles visible under ultrasound, without visible follicle growth. The project also seeks to enable patients to conceive offspring carrying their own genetic material through in vitro fertilization (IVF) technology.
详细描述
Inclusion Criteria:
- Females under 40 years of age with amenorrhea or oligomenorrhea for at least four months, and elevated follicle-stimulating hormone (FSH) levels > 25 IU/l on two separate occasions (with a 4-week interval);
- Ultrasound (B-mode) indicating no antral follicle development in both ovaries for at least 3 months prior to study participation;
- Those who agree to participate in this study and voluntarily sign the informed consent form.
Exclusion Criteria:
- Individuals over 40 years of age, or under 40 years of age with regular menstruation, normal ovulation, amenorrhea or oligomenorrhea for less than 4 months, and elevated follicle-stimulating hormone (FSH) levels < 25 IU/l on two or more separate occasions (with a 4-week interval);
- Those with contraindications to the use of injectable human chorionic gonadotropin (HCG);
- Those with asthma, epilepsy, heart disease, migraines, renal impairment, hypertension, or other diseases;
- Patients deemed by the researcher as otherwise unsuitable for participation in this study.
Withdrawal criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females under 40 years of age with amenorrhea or oligomenorrhea for at least four months, and elevated follicle-stimulating hormone (FSH) levels > 25 IU/l on two separate occasions (with a 4-week interval);
- •Ultrasound (B-mode) indicating no antral follicle development in both ovaries for at least 3 months prior to study participation;
- •Those who agree to participate in this study and voluntarily sign the informed consent form.
排除标准
- •Individuals over 40 years of age, or under 40 years of age with regular menstruation, normal ovulation, amenorrhea or oligomenorrhea for less than 4 months, and elevated follicle-stimulating hormone (FSH) levels < 25 IU/l on two or more separate occasions (with a 4-week interval);
- •Those with contraindications to the use of injectable human chorionic gonadotropin (HCG);
- •Those with asthma, epilepsy, heart disease, migraines, renal impairment, hypertension, or other diseases;
- •Patients deemed by the researcher as otherwise unsuitable for participation in this study."
研究组 & 干预措施
In vitro fertilization - Embryo transfer
Other
Embryo vitrification and freezing were performed after fertilization of oocytes.
干预措施: human chorionic gonadotropin (Drug)
结局指标
主要结局
focilles
时间窗: Interval of 1-2 weeks after HCG injection
Bilateral ovarian follicles were monitored by ultrasound
次要结局
- sex hormone(Interval of 1-2 weeks after HCG injection)
- Oocyte(After the egg retrieval operation, the eggs are picked up and observed)
- Embryo(3-5 days after In vitro fertilization)
- Pregnancy outcome(One month after embryo transfer)
- The health of the offspring(One year after birth)
研究者
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