Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of live birth in a year of fertility attempt
研究概览
简要总结
Purpose of this study:
To establish the superiority of myomectomy versus Uterine Artery Embolization, in women with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.
详细描述
Background:
The use of uterine artery embolization (UAE) to treat symptomatic fibroids in women seeking future fertility remains a matter of debate, because of possible adverse effects on ovarian reserve and embryo implantation. In women with associated infertility factors, not eligible for myomectomy, poor fertility was obtained after UAE. On the other hand, fertility of women eligible for surgical myomectomy, deciding to have a UAE, compares favourably with the fertility obtained after myomectomy.
Study design:
Eligible women will be explored to pull out any other infertility factors such as:
- tubal factors (no hydrosalpinx at MRI, tubal permeability assessed by hysterosalpingography and/or negative serology of for Chlamydia)
- Endometriosis (clinical history and examination, MRI)
- Ovarian factors (normal AMH dosage, and Antral follicular count)
- Male factors (normal spermogram of the Partner if possible)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Women aged ≥ 18 and ≤ 43 years old
- •At least one interstitial fibroid more than 3 cm on MRIat MRI)
- •with symptoms: genital bleeding, chronic pelvic pain or heaviness, anemia, or infertility > 1 year.
- •With immediate desire to conceive
- •without assisted reproductive indication: no tubal infertility, menstrual irregularities, hydrosalpinx, endometriosis, adenomyosis, or male infertility.
- •Patient with health insurance, who can read and understand French and who has given written consent
排除标准
- •Ongoing regnancy
- •Emergency Situation
- •Contraindication to surgery or uterine embolization: allergy to contrast medium , renal failure, immunodeficiency, contraindication to anesthesia, subserosal or submucosal pedunculated fibroids, fibroids with largest diameter inside of the uterine cavity
结局指标
主要结局
Number of live birth in a year of fertility attempt
时间窗: 18 months
Women will be allowed to attempt fertility 6 months after treatment. Effective fertility attempts will be prospectively followed. Final fertility will be assessed one year later.
次要结局
- number of adverse effects on fertility (ovarian reserve markers)(18 months)
- number of adverse effects on fertility (state of the endometrium(18 months)
- Number of adverse effects during pregnancy : small for gestational age(Until 30 months)
- Number of adverse effects during pregnancy : foetal death(Until 30 months)
- number of adverse effects on fertility (state of the uterine cavity)(18 months)
- Quality of life With QSF questionnaires, a French version of the WHQ questionnaire(18 months)
- Number of adverse effects during pregnancy : Rate of Miscarriage(Until 30 months)
- Number of adverse effects during pregnancy : abnormal placental position and implantation(Until 30 months)
- Number of adverse effects during pregnancy : delivery hemorrhagy(Until 30 months)
- Improvement of symptoms related to fibroids With UFS-QoL questionnaires(18 months)
- Number of adverse effects during pregnancy : extra-uterine pregnancy(until 24 months)
- Number of adverse effects during pregnancy : uterine rupture(Until 30 months)
- Number of adverse effects during pregnancy : preterm delivery(Until 29 months)
- number of adverse effects in the newborn(At day 3 of life)