Impact of Double Stimulation (DuoStim) in Women Affected by Low Prognosis to Assisted Reproductive Technologies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cumulative Ongoing pregnancy rate
研究概览
简要总结
The main objective of this study is to compare the cumulative ongoing pregnancy rates of two different IVF protocols in women candidate for ART characterized by low prognosis.
详细描述
The patients will be allocated into two groups: control and study group _ In study group, patients will be treated by DuoStim protocol: The first phase of ovarian stimulation is started on the second day or third day of period. GnRH agonist will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. Five days later after oocyte retrieval, the second stimulation will be started. All embryos will be cryopreserved.
_ In control group, patients will be treated with antagonist protocol: The cycle of ovarian stimulation is started on the second day or third day of period. hCG will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. If serum progesterone on the day of trigger ≥ 1.5 ng/ml, all embryos will be cryostored; otherwise, fresh embryos will be transferred.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •AMH ≥ 0.3 ng/ml and ≤ 1.2 ng/ml.
- •OR 3 ≤ AFC ≤
- •Normal shape of uterus (based on ultrasound).
- •Body mass index within 28 - 37 kg/m2
排除标准
- •Asherman's syndrome.
- •Endometriosis.
- •Leiomyomas distorting the endometrium
- •Sperm extracted from surgical procedures (i.e. PESA, TESE).
- •Patients refuse to continue participating in the study.
- •Patients injected with wrong dose of gonadotropins during the treatment.
- •Serious complications or accidents arise forcing the patients to discontinue the treatments.
- •Ovarian surgery
- •Previous chemotherapy or pelvic irradiation
结局指标
主要结局
Cumulative Ongoing pregnancy rate
时间窗: week 11 - 14 of pregnancy
calculated by the number of ongoing pregnancy patients divided by the total number of patients in appropriate group
次要结局
- Pregnancy rate(2 weeks after embryo transfer)
- Fertilization rate(1 to 3 days after oocyte pick-up)
- Number of mature oocytes(4 hours after oocyte pick-up)
- Ongoing pregnancy rate(week 11 - 14 of pregnancy)
- Number of oocytes retrieved(4 hours after occyte pick-up)
- Number of competent embryos(3 days to 5 days after oocyte pick-up)
研究者
Le Thi Minh Chau
Head of department of Infertility
Tu Du Hospital