Département de Médecine de la Reproduction, Centre Hospitalier Régionnal Universitaire de Montpellier
Montpellier, 34000, France
NCT Number: NCT02577055
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.
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Notify Me18 year–43 year
Female
Interventional
Not applicable
Montpellier, 34000, France
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:
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Fertility sparing ultra selective uterine artery embolization
Time frame: 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.
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
Time frame: 3 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 3 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: Until 30 months
Time frame: until 24 months
Time frame: Until 30 months
Time frame: Until 30 months
Time frame: Until 30 months
Time frame: Until 30 months
Time frame: Until 29 months
Time frame: Until 30 months
Time frame: 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)
Assistance Publique - Hôpitaux de Paris
Other
Acronym: Lune2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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