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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01868-33 | Registry Identifier | Agence nationale de sécurité du médicament et des produits de santé |
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| Name | Class |
|---|---|
| Gedeon Richter France | UNKNOWN |
| Collège National des Gynécologues et Obstétriciens Français | UNKNOWN |
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Uterine leiomyomas (or fibroids) are a common disease (30% of women over 35 years of age) in women of childbearing age and can cause various symptoms such as menometrorrhagia, dysmenorrhoea, pelvic pain and heaviness, and infertility.
Uterine artery embolisation, first used in France in 1990, is a safe, effective and less invasive therapeutic technique than surgical treatment (myomectomy or hysterectomy), particularly in the case of numerous and large fibroids. This technique is validated by the French National College of Gynaecologists-Obstetricians (CNGOF) as an alternative treatment for women who do not wish to become pregnant (grade A recommendation), but at present there is little reliable data concerning fertility, the occurrence of pregnancy and the obstetrical prognosis after uterine artery embolisation for fibroids. A recent systematic review of the literature with meta-analysis published very recently showed that 40.5% of patients with a desire for pregnancy were able to become pregnant after embolisation (CI: 33.3%-48.2%) but that the rates of miscarriage, obstetric complications and low birth weight were not negligible (respectively 33.5% (95% CI: 26.3-41%), 25.4% (95% CI = 13-40.2%) and 10% (95% CI = 6.2-14.6%) (Ghanaati et al. 2020).
In France, uterine artery embolisation is performed in more than thirty centres in women who have completed their parental project. On the other hand, in the absence of consistent literature, it is performed in patients of childbearing age, when it represents the only acceptable alternative or in the event of contraindication or refusal of surgery by the patient. To our knowledge, there is no large-scale French study to date on the impact of embolisation on fertility and pregnancy outcomes.
The aim of this study is to compile a retrospective database of all cases of uterine artery embolisation for uterine pathology performed at the Georges-Pompidou European Hospital (HEGP) since 2007 and to assess the impact of embolisation on fertility in patients of childbearing age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female who underwent uterine artery embolisation for uterine pathology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrospective data collection | Other | Data collection from the medical file of the patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of live births after embolisation | Rate of live births after embolisation (percentage) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Obstetrical outcomes after embolisation |
| one year |
| Effectiveness and safety of embolisation |
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Inclusion Criteria:
Exclusion Criteria:
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Female aged 18 to 45 years who underwent uterine artery embolisation for uterine pathology in our institution between 2007 and September 2020
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| Name | Affiliation | Role |
|---|---|---|
| Henri Azaïs, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41094296 | Derived | Fabre C, Boeken T, Simon V, Dean C, Sapoval M, Pellerin O, Bats AS, Azais H, Koual M. Fertility outcomes after uterine artery embolization for symptomatic leiomyomas. CVIR Endovasc. 2025 Oct 16;8(1):83. doi: 10.1186/s42155-025-00604-4. |
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Individual participant data (IPD) that underlies results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.
Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement.
Processing of shared data must comply with European General Data Protection Regulation (GDPR).
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| Phone interview | Other | Call for collecting fertility data and obstetrical issues of the patients |
|
|
| one year |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |