A Retrospective, National, Multicenter Study Evaluating the Impact of Ulipristal Acetate (Esmya®) on Infertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques (ART)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 23
- 主要终点
- Clinical pregnancy
研究概览
简要总结
Fibroid is a frequent pathology of infertile women. Its deleterious effect on the infertility would be due to the mechanical way.
The interest of the resection of intramural fibroids is discussed. It is necessary to measure the indication of a myomectomy, whatever the surgical procedure. On the one hand, it may cause important potential complications, and on the other hand, the surgery does not improve the parameters of the fertility.
Thus, it is a major stake to avoid the surgical operation. A decrease of the size of these fibroids by medical treatment is then a good option.
When the surgical treatment is necessary, a medical pre-surgical treatment is often proposed in order to decrease the symptomatology and to reduce the size of the fibroid to facilitate the surgery.
Acetate Ulipristal (UPA) has been marketed in this indication. Following the Pearl I-II studies, the first indication in France was a pre-surgical treatment for 3 months at a dose of 5 mg per day.
The Pearl III and IV studies evaluated the Esmya® administration as a long-term intermittent repeated treatment, giving to it a prominent position for the long-term management of symptomatic fibroids.
Furthermore, cases of pregnancy before surgery are frequently described in women with fibroids treated by UPA for a pre-IVF surgery.
5 to 10 % of women who are managed for infertility have fibroids and only 2% to 3% have this unique cause of infertility.
Then, some of patients followed in ART centers have been treated by UPA to reduce the fibroids size and/or to decrease the associate symptoms.
The aim of this study is to evaluate in the different French ART centers, the impact on fertilization of UPA administration for infertile women with fibroids and to describe the modalities of its prescriptions and to collect information regarding safety tolerance profile of Esmya® in this patient population.
详细描述
A retrospective, national, multicenter study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 43 years 'old at the time of the beginning of ulipristal acetate intake
- •Women with fibroid at the time of ulipristal acetate prescription
- •Women with desire to have children and managed for infertility in an ART center (whatever the type of infertility treatment)
- •Women having received a treatment by ulipristal acetate
- •Data collected between 2013/12/01 and 2018/06/30 ; data collected between ulipristal acetate prescription until the term of pregnancy or embryo transfer failure (up to 4) or death/lost to follow up or ART treatment discontinuation
排除标准
- 未提供
结局指标
主要结局
Clinical pregnancy
时间窗: 15 days
Clinical pregnancy rate after maximum 4 embryos transferred by IVF/ICSI procedures ; pregnancy is defined by beta-hCG\> 1000 or presence of a gestation sac
次要结局
- Live birth / miscarriage(9 months)
- Spontaneous pregnancy(at least 2 months)
- Surgery rate(3 months)
- Safety impact on ulipristal acetate administration(20 months)
- Ulipristal acetate safety analysis in infertile women with fibroids(20 months)
- Fibroids size(Baseline (before ulipristal acetate administration) and 20 months)
- Surgery description(3 months)
- Description of ulipristal acetate prescription(20 months)
研究者
Catherine Rongieres
Head of the ART center of the University Hospital of Strasbourg
ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO