Does Subcutaneous Granulocyte Colony Stimulating Factor (G-CSF) Improve Ovarian Reserve in Women With Premature Ovarian Insufficiency?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Improving ovarian reserve markers
研究概览
简要总结
The goal of this pilot study is to improve ovarian reserve markers in patients with premature ovarian insufficiency. The main question it aims to answer is:
- Will treatment with G-CSF allow improvement in markers of ovarian reserve?
详细描述
The research team hypothesize that treatment of premature ovarian insufficiency patients with G-CSF to mobilize bone marrow hematopoietic stem cells will allow for improved ovarian reserve markers including antral follicle count, anti-Mullerian hormone (AMH) levels and gonadotropin (FSH) levels. The research team anticipate these outcomes:
- Primary outcome: Decreased serum FSH and increased AMH levels and u/s measurement of increased antral follicle count (AFC)
- Secondary outcome: Improved ovarian response in IVF cycles if BAFs develop, and spontaneous or IVF pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ages 25-40
- •Woman who meet criteria for POI defined as AFC < 5, AMH < 3 pmol/L and FSH >30 IU/L. There may also be associated symptoms of the menopause such as hot flushes, night sweats, insomnia and vaginal dryness.
- •Women who are not taking any other medical or fertility treatments except natural estrogen to stop hot flushes.
- •Those who are provided with informed consent.
排除标准
- •Women with age > 40
- •Women with history of autoimmune disorders
- •Women with a history of hematopoietic cell malignancies
- •Women with sickle cell disease
- •Women with any other comorbidities that would preclude infertility treatment and pregnancy such as HIV/AIDS, hepatitis B or C, breast cancer or body mass index (BMI) >40.
研究组 & 干预措施
Patients with POI receiving G-CSF injections
Patients will receive 0.5 ml SC injections of G-CSF (Neupogen, Amgen, USA) at 300 micrograms/day for 4 consecutive days. The first injection will be administered in our office with a 60-minute observation period. Subsequent injections can be self-administered at home for three days, with a return to our clinic for monitoring the following day. This 4-day Neupogen regimen will be repeated in one month.
Patients may undergo two rounds of G-CSF treatment one month apart. If no improvement is observed in gonadotropin, anti-Mullerian levels, and antral follicle count, a third treatment may be offered a month later. Follow-up includes blood assessment of AMH and FSH, as well as ultrasound measurement of basal antral follicle count for three months after the last G-CSF infusion.
干预措施: Neupogen (Drug)
结局指标
主要结局
Improving ovarian reserve markers
时间窗: It is anticipated within six months
Success of the treatment will be assessed by a change in serum FSH, AMH (measure of ovarian reserve) and number of antral follicles (AFC).
FSH Level (IU/L)
时间窗: Baseline to Month 12
Success of the treatment will be assessed by a change in serum FSH, AMH (measure of ovarian reserve) and number of antral follicles (AFC).
AMH Level (Pmol/L)
时间窗: Baseline to Month 12
AMH level for ovarian reserve
次要结局
- Successful Pregnancy(It is anticipated after the first six months of the study time frame)
- Successful Pregnancy(From Baseline to Month 12)
研究者
Dr. Robert F. Casper
Scientific Director, MD, FRCSC, REI
Trio Fertility