Efficacy of Ulipristalacetate in Comparison to Surgery Before IVF/ICSI-treatment in Women With Intramural Fibroids: Effect on Reproductive Outcome.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ongoing pregnancy rates
研究概览
简要总结
Studying the possible outcome differences between surgery or medical treatment with ulipristalacetate (UPA) solely before 'in-vitro fertilisation/intracytoplasmic sperm injection' (IVF/ICSI) treatment in infertile couples.
详细描述
Uterine fibroids are the most common benign uterine tumors in women of reproductive age. Symptoms are depending on size, number and localisation of the fibroids. Heavy menstrual bleeding, anaemia, abdominal pain, dyspareunia and urinary symptoms are often put forward.
Intramural and especially submucous myomas are known to decrease fertility and augment miscarriage rate. Some studies have demonstrated a negative effect of intramural fibroids on fertility outcome, while others do not. A recent meta-analysis found adverse pregnancy outcomes associated not only with submucous and intramural fibroids distorting the uterine cavity, but also with intramural fibroids not distorting the cavity.
Ulipristalacetate (Esmya®) is currently used to pre-treat symptomatic women with fibroids before surgical intervention. Esmya® has been demonstrated to be safe and effective in the treatment of fibroids. Due to apoptosis sometimes a reduction in volume of the myoma is seen. This effect could influence the fertility and operative outcome.
Current options are available before assisted reproductive technology (ART) for infertile women diagnosed with fibroids:
- no treatment
- medical pre-treatment before ART:
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
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1st, 2nd or 3th IVF/ICSI attempt
- •infertility Indications:
- •unexplained
- •male/donor sperm
- •endometriosis I/II
- •Body Mass Index (BMI) >18 - < 30
- •Basal Follicle Stimulating Hormone (FSH) < 10 IU/L
- •anti-mullerian hormone (AMH) > 1 ng/ml
- •Normal ultrasound apart from the following:
- •Type 2 fibroid : ≤2cm diameter
- •Type 3 - 5 fibroids: with diameter ≥ 3 and ≤10cm according to classification of European Society for Gynecological Endoscopy (ESGE )
排除标准
- •More than 2 submucous fibroids
- •Poor responders
- •Severe male factor
研究组 & 干预措施
Ulipristalacetate group
patients treated by ulipristalacetate before starting IVF/ICSI treatment
干预措施: Ulipristal Acetate 5 MG Oral Tablet (Drug)
结局指标
主要结局
ongoing pregnancy rates
时间窗: 2 years
次要结局
- Time to pregnancy(2 years)
- Obstetric outcome described as live birth(2 years)
- Miscarriage rate(2 years)
研究者
Stefan Cosyns
Principal Investigator
Universitair Ziekenhuis Brussel