Effects of Intramural Fibroids That do Not Distort the Uterine Cavity on IVF Outcome
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
A cohort study involving 200 women candidate for IVF / ICSI cycles . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts.
On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),
, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.
详细描述
A cohort study involving 200 women candidate for IVF / ICSI cycles . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts.
On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),
, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age younger than 40 years
- •FSH) less than 10 IU/L
- •serum prolactin level normal
- •uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography.
排除标准
- •abnormal endocrine function (e.g. abnormal thyroid or adrenal function)
- •ovarian cysts,
- •hydrosalpinx
- •endometrial polyps
- •male partner with azoospermia
- •ICSI performed for preimplantation genetic diagnosis.
研究组 & 干预措施
Non fibroid group
Women without myomas
干预措施: human chorionic gonadotropin (Drug)
Fiboroid group
Women with intramural myoma no reaching the cavity
干预措施: Gonadotropins (Drug)
Fiboroid group
Women with intramural myoma no reaching the cavity
干预措施: human chorionic gonadotropin (Drug)
Fiboroid group
Women with intramural myoma no reaching the cavity
干预措施: Ovum pick up (Procedure)
Fiboroid group
Women with intramural myoma no reaching the cavity
干预措施: Embryo transfer (Procedure)
Non fibroid group
Women without myomas
干预措施: Gonadotropins (Drug)
Non fibroid group
Women without myomas
干预措施: Ovum pick up (Procedure)
Non fibroid group
Women without myomas
干预措施: Embryo transfer (Procedure)
结局指标
主要结局
clinical pregnancy rate
时间窗: 4 weeks after embryo transfer
appearance of one or more intrauterine gestational sac
次要结局
未报告次要终点
研究者
Ahmed M Maged, MD
Principal investigator
Cairo University