The Value of Myomectomy in Women With Intramural Myoma Before IVF. A Randomized Controlled Trial

Cairo University1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2019年4月最近更新: 2019年4月5日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Cairo University
入组人数: 100
试验地点: 1
主要终点: clinical pregnancy rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention . 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

Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention .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),

研究设计

研究类型: Interventional
分配方式: 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: 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

Conservative group

Active Comparator

women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization

干预措施: Gonadotropins (Drug)