Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids
Condition: Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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)

      Women will be treated with fertility sparing ultra selective uterine artery embolization, or
      surgical removal of multiple myomas.

      A six months convalescence/cicatrisation period will be respected, then women will be allowed
      to intend to conceive.

      Several elements will be prospectively followed:

        -  Spontaneous pregnancy from 6 months to 18 months after treatment

        -  Pregnancy outcomes

        -  Symptoms and quality of live with UFS-QoL and WHQ questionnaires, at 3, 6, 12 and 18
           months after treatment

        -  Uterine size with MRI, before and 3 months after treatment.

        -  Aspect of the uterine cavity with hysteroscopy before and 3 months after treatment.

        -  Ovarian reserve with AMH dosage, and Antral follicular count before and 3 months after
           treatment.

        -  Volume and molecular pattern of the endometrium at the implantation window before and 3
           months after treatment (optional).

        -  Treatment's adverse effects.
    

Intervention name(s): myomectomy; embolisation
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgical ablation of all fibroids; Embolisation of the peri-myoma vascular network, with non-resorbable particles of >500 µm diameter, using an ultra thin catheter introduced through the vascular network up to the uterine arteries under radioscopic control.
Other intervention name(s): Fertility sparing ultra selective uterine artery embolization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Leiomyoma; Uterine Artery Embolization; Surgery; childbearing age; Fertility; Noninferiority trial