Ambispective Comparative Cohort Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin on ICSI and Vitrified-Warmed Embryo Transfer Outcomes in Women With Adenomyosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- ongoing pregnancy
研究概览
简要总结
The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms
详细描述
The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms:
Arm 1: Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI Arm 2: Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI Primary and secondary key measurements will be used in the study.
The primary measures will include:
- Presence of intrauterine gestational sac at 12 weeks
- Presence of fetal heart pulsation at 12 weeks
The secondary key measures will include:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 42 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed using both the transvaginal ultrasound study (TVS) and MRI criteria
- •Main criteria for sonographic and MRI diagnosis of adenomyosis are:
- •The appearance of asymmetrical thickening of the myometrium Irregular cystic areas within the myometrium Linear striations radiating out from the myometrium
- •Patients ≤42 years old at the time of starting ICSI cycle
- •Cryopreserved embryo transfer cycles
- •The presence of at least one good cryopreserved day 3 embryo.
排除标准
- •Transfer of a poor-quality embryo (grades 3 or 4)
- •History of myomectomy
- •Pelvic ultrasound that showed the presence of uterine fibroids, a hydrosalpinx or endometrial polyps (all known causes of implantation failure).
结局指标
主要结局
ongoing pregnancy
时间窗: up to 13 weeks gestation
- Recording the following for the two arms of the study: Presence of intrauterine gestational sac at 12 weeks Presence of fetal heart pulsation at 12 weeks
次要结局
- Recording the baseline characteristics of the study participants(Before study intervention)
- Occurance of abortion or ectopic(up to 13 weeks gestation)
研究者
Wael Elbanna
Managing director for Wael Elbanna Clinic
Wael Elbanna Clinic