Comparison of the Number of Oocytes Obtained Between Chinese and Caucasian Women Undergoing in Vitro Fertilization Treatment With a Standard Ovarian Stimulation Regimen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Number of oocytes obtained
研究概览
简要总结
IVF is a well-established method to treat various causes of infertility. Some studies have suggested that ethnicity affects the success of IVF. This is a prospective study involving two tertiary IVF units in Hong Kong and Australia. The IVF outcome between Chinese and Caucasians will be compared.
详细描述
This is a prospective study conducted in two tertiary IVF units in Hong Kong and Australia.
The target population for the trial will be women undergoing IVF or intracytoplasmic sperm injection (ICSI) treatment in two IVF Units.
Intervention:
Patients recruited in this study will undergo IVF+/-ICSI treatment. They will undergo an ultrasound scan on the second or third day (day 2 or 3) of a period to exclude the presence of ovarian cyst and have the antral follicle count determined, which includes all follicles of 2-10 mm measured with a 5.5-7.5mHz transvaginal ultrasound probe. Blood will be checked for anti-mullerian hormone (AMH) measured by Beckman-Coulter Diagnostics.
Ovarian stimulation will be started if there are no ovarian cysts on ultrasound scan. They will receive one long acting gonadotrophin injection Elonva 150 microgram subcutaneously followed by daily gonadotrophin injections (Puregon) 200 IU in an antagonist protocol. Antagonist (orgalutran 0.25 mg) will be started on day 5 of ovarian stimulation. Transvaginal ultrasound will be performed for follicular tracking 7 days after the Elonva injection and every 1-3 days thereafter. No adjustment in FSH dose is allowed. Cycles will be cancelled if there are less than 3 follicles larger than 18mm after one week of 200 IU Puregon or there no developing follicle (i.e. larger than 11mm) after one week of 200 IU Puregon.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 18-36 years old
- •Body weight >60Kg
- •Total antral follicle count >=7 and ≤ 20 i.e. not poor ovarian reserve based on Bologna criteria
- •Chinese women in the HK centre and Caucasian women (defined as originating from the United Kingdom, Europe or United States of America, excluding the Middle East) in the Australian centre
- •Written informed consent
排除标准
- •Mixed race/ ethnicity
- •History of ovarian surgery
- •Body mass index >35 kg/m2
- •>2 previous stimulated IVF cycles
- •History of ovarian hyperstimulation syndrome in previous stimulated IVF cycles
- •Polycystic ovary syndrome or total antral follicle count >20
结局指标
主要结局
Number of oocytes obtained
时间窗: 17 days
Number of oocytes obtained
次要结局
- Serum progesterone levels on day 9 and day of hCG(9 and day of hCG)
- Ongoing pregnancy rate(12 weeks)
- Serum LH levels on day 9 and day of hCG(9 and day of hCG)
- Clinical pregnancy rate(6 weeks)
- Ovarian hyperstimulation rate(8 weeks)
- Dosage of recombinant FSH(15 days)
- Serum estradiol levels on day 9 and day of hCG(9 and day of hCG)
- Miscarriage rate(24 weeks)
- Live birth rate(44 weeks)
- Number of follicles smaller than 14, 16mm and larger than 18mm in diameter on day 8 and day of hCG(8 and day of hCG)
- Serum FSH levels on day 9 and day of hCG(9 and day of hCG)
- Duration of recombinant FSH(15 days)