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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
9
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.
Département de Médecine de la Reproduction, Centre Hospitalier Régionnal Universitaire de Montpellier
Montpellier, France
Number of live birth in a year of fertility attempt
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.
Time frame: 18 months
number of adverse effects on fertility (ovarian reserve markers)
Time frame: 18 months
number of adverse effects on fertility (state of the uterine cavity)
Time frame: 18 months
number of adverse effects on fertility (state of the endometrium
Time frame: 18 months
Improvement of symptoms related to fibroids With UFS-QoL questionnaires
Time frame: 3 months
Improvement of symptoms related to fibroids With UFS-QoL questionnaires
Time frame: 6 months
Improvement of symptoms related to fibroids With UFS-QoL questionnaires
Time frame: 12 months
Improvement of symptoms related to fibroids With UFS-QoL questionnaires
Time frame: 18 months
Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
Time frame: 3 months
Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
Time frame: 6 months
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Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
Time frame: 12 months
Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
Time frame: 18 months
Number of adverse effects during pregnancy : Rate of Miscarriage
Time frame: Until 30 months
Number of adverse effects during pregnancy : extra-uterine pregnancy
Time frame: until 24 months
Number of adverse effects during pregnancy : small for gestational age
Time frame: Until 30 months
Number of adverse effects during pregnancy : foetal death
Time frame: Until 30 months
Number of adverse effects during pregnancy : uterine rupture
Time frame: Until 30 months
Number of adverse effects during pregnancy : abnormal placental position and implantation
Time frame: Until 30 months
Number of adverse effects during pregnancy : preterm delivery
Time frame: Until 29 months
Number of adverse effects during pregnancy : delivery hemorrhagy
Time frame: Until 30 months
number of adverse effects in the newborn
Rate of small for gestational age, delivery presentation, health of newborn children (Apgar score, cord pH, admission in the neonatology service)
Time frame: At day 3 of life