Leiomyoma
Conditions
Keywords
Leiomyoma, Uterine Artery Embolization, Surgery, childbearing age, Fertility, Noninferiority trial
Brief 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.
Interventions
PROCEDUREmyomectomy
Surgical ablation of all fibroids
PROCEDUREembolisation
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.
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of live birth in a year of fertility attempt | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of adverse effects on fertility (state of the uterine cavity) | 18 months | — |
| number of adverse effects on fertility (state of the endometrium | 18 months | — |
| Improvement of symptoms related to fibroids With UFS-QoL questionnaires | 3 months | — |
| Quality of life With QSF questionnaires, a French version of the WHQ questionnaire | 3 months | — |
| Number of adverse effects during pregnancy : Rate of Miscarriage | Until 30 months | — |
| Number of adverse effects during pregnancy : extra-uterine pregnancy | until 24 months | — |
| number of adverse effects on fertility (ovarian reserve markers) | 18 months | — |
| Number of adverse effects during pregnancy : foetal death | Until 30 months | — |
| Number of adverse effects during pregnancy : uterine rupture | Until 30 months | — |
| Number of adverse effects during pregnancy : abnormal placental position and implantation | Until 30 months | — |
| Number of adverse effects during pregnancy : preterm delivery | Until 29 months | — |
| Number of adverse effects during pregnancy : delivery hemorrhagy | Until 30 months | — |
| number of adverse effects in the newborn | At day 3 of life | Rate of small for gestational age, delivery presentation, health of newborn children (Apgar score, cord pH, admission in the neonatology service) |
| Number of adverse effects during pregnancy : small for gestational age | Until 30 months | — |
Countries
France
Outcome results
None listed