Cohort Profile：The Shandong Adenomyosis Cohort of Population Undergoing Reproductive Technology (SAart)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,241
- 试验地点
- 1
- 主要终点
- cumulative live birth rate
研究概览
简要总结
Previous studies have shown that compared with infertile women without adenomyosis, the clinical pregnancy rate, live birth rate and continuous pregnancy rate of women with adenomyosis significantly reduce, and the abortion rate obviously increased. However, these studies lack a definite classification of adenomyosis, so the true effect of adenomyosis with different severity on pregnancy outcomes are not clear. Our research team intends to collect clinical data of infertility patients with adenomyosis receiving IVF and the detailed classification of adenomyosis according to MUSA criteria. Finally, we can have an objective recognition of adenomyosis on pregnancy outcomes, which also bring benefits to evidence-based clinical practice.
详细描述
Previous studies have shown that compared with infertile women without adenomyosis, the clinical pregnancy rate, live birth rate and continuous pregnancy rate of women with adenomyosis significantly reduce, and the abortion rate obviously increased. However, these studies lack a definite classification of adenomyosis, so the true effect of adenomyosis with different severity on pregnancy outcomes are not clear. Our research team intends to collect clinical data of infertility patients with adenomyosis receiving IVF and the detailed classification of adenomyosis according to MUSA and ultrasound consensus. Finally, we can have an objective recognition of adenomyosis on pregnancy outcomes, which also bring benefits to evidence-based clinical practice.
The detailed inclusion and exclusion criteria are as follows:
Inclusion criteria
1.Age of all participants ≥ 20 and < 38 years. 2.Receiving IVF treatment because of adenomyosis or other common factor, such as fallopian tube factors.
3.Conforming to MUSA criteria. 4. Body mass index < 30 kg/m2. 5.The level of AMH ≥ 0.8 ng/ml. Exclusion criteria
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age of all participants ≥ 20 and< 38 years.
- •Receiving IVF treatment because of adenomyosis or other common factor, such as fallopian tube factors.
- •Conforming to MUSA criteria.
- •Body mass index < 30 kg/m
- •The level of AMH ≥ 0.8 ng/ml.
排除标准
- •Uterine fibroids (International Federation of Gynecology and Obstetrics (FIGO) type 0--I--II or type III--IV fibroids < 3 cm).
- •Untreated endometrial polyps, hydrosalpinges or uterine adhesions.
- •RSA or RIF.
- •Intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT).
- •Concurrent and/or recent involvement in other research within previous 3 months of study
结局指标
主要结局
cumulative live birth rate
时间窗: from pregnancy to delivery
The numerator is number of live births from fresh or frozen embryo transfer in one ovarian stimulation cycle. More than one live birth is considered as one live birth. Denominator is defined as patients who have undergone oocyte retrieval and have either achieved at least one live birth or who have no surplus embryos.
次要结局
- implantation rate(from transplantation to delivery)
- biochemical pregnancy rate(from transplantation to pregnancy)
- ectopic pregnancy rate(from transplantation to clinical pregnancy)
- miscarriage rate(pregnancy loss before 28 gestational weeks)
- clinical pregnancy rate(pregnancy loss before 28 gestational weeks)
研究者
Linlin Cui
Professor
The Second Hospital of Shandong University