Fertility DisordersFERTI-EMBOLNCT05271981
Fertility After Uterine Artery Embolization
An observational study of Fertility Disorders and Fertility Issues, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fertility Disorders, Fertility Issues, Myoma;Uterus
- What is being tested?
- Retrospective data collection and Phone interview
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2022to 29 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Female aged 18 to 45 years who underwent uterine artery embolisation for uterine pathology in our institution between 2007 and September 2020
Who may be able to join
- Women ≥ 18 years, ≤ 45 years at the time of their embolisation
- Uterine pathology responsible for disabling symptoms: uterine leiomyomas with no limitations in size, number or location, adenomyosis
- Having had a uterine artery embolisation between 2007 and September 2020
- Minimum delay of one year after embolisation
- Information and no opposition from patients
Who cannot join
- Women < 18 years and > 45 years at the time of embolisation
- Uterine artery embolisation for delivery haemorrhage
- Patients under court protection, guardianship or curatorship
- Refusal to participate in this research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterine Artery Embolization For Uterine Pathology: What Impact On Fertility?
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).
Read more
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.
- Being tested
- Retrospective data collection, Phone interview
- Keywords
- uterine artery embolisation, Fertility Issues, Fertility Disorders, uterine myoma
- Medical subject headings
- Infertility, Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective data collectionOther
Data collection from the medical file of the patients
Phone interviewOther
Call for collecting fertility data and obstetrical issues of the patients
| Study group | Role | What they receive |
|---|---|---|
| Female who underwent uterine artery embolisation for uterine pathology | Not described Receives: Other: Retrospective data collection; Other: Phone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of live births after embolisation
Rate of live births after embolisation (percentage)
Measured: one year
Secondary outcomes (2)
Obstetrical outcomes after embolisation
- Pregnancy rate (percentage) ;
- Miscarriage rate (percentage) ;
- Assisted reproduction rate;
- Obstetric complication rates (haemorrhage, caesarean section, prematurity, pre-eclampsia, placental disorders)
Measured: one year
Effectiveness and safety of embolisation
- Complication rate of embolisation (percentage)
- Post-embolisation myomectomy and hysterectomy rates (percentage)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start23 Nov 2022
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Gedeon Richter France, Collège National des Gynécologues et Obstétriciens Français
- Responsible party
- Sponsor
- Investigators
- Henri Azaïs, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271981
- Sponsor's protocol ID
- APHP21114
- Other IDs
- 2021-A01868-33
- Acronym
- FERTI-EMBOL
- Status last verified
- Apr 2026
- First submitted
- 28 Feb 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlies results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Publications
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.
PubMed 41094296
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Artery Embolization For Uterine Pathology: What Impact On Fertility?
- ClinicalTrials.gov ID
- NCT05271981
- Acronym / sponsor ID
- FERTI-EMBOL / APHP21114
- Keywords
- uterine artery embolisation, Fertility Issues, Fertility Disorders, uterine myoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Gedeon Richter France, Collège National des Gynécologues et Obstétriciens Français
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female who underwent uterine artery embolisation for uterine pathology | – | Other: Retrospective data collection, Other: Phone interview |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female aged 18 to 45 years who underwent uterine artery embolisation for uterine pathology in our institution between 2007 and September 2020
Key inclusion criteria (5 listed)
- Women ≥ 18 years, ≤ 45 years at the time of their embolisation
- Uterine pathology responsible for disabling symptoms: uterine leiomyomas with no limitations in size, number or location, adenomyosis
- Having had a uterine artery embolisation between 2007 and September 2020
- Minimum delay of one year after embolisation
- Information and no opposition from patients
Key exclusion criteria (4 listed)
- Women < 18 years and > 45 years at the time of embolisation
- Uterine artery embolisation for delivery haemorrhage
- Patients under court protection, guardianship or curatorship
- Refusal to participate in this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective data collectionData collection from the medical file of the patients | Other | Female who underwent uterine artery embolisation for uterine pathology |
| Phone interviewCall for collecting fertility data and obstetrical issues of the patients | Other | Female who underwent uterine artery embolisation for uterine pathology |
Primary outcome
Rate of live births after embolisation
Time frame: one year
Rate of live births after embolisation (percentage)
2 secondary outcomes
Obstetrical outcomes after embolisation
Time frame: one year
Effectiveness and safety of embolisation
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Derived from this study: PubMed 41094296Fabre 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlies results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Related trials for Fertility Disorders
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
Active, not recruitingPhase 2
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
Endometrial Neoplasm Malignant Stage I
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Not yet recruitingPhase 2
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
Endometrioid Endometrial Cancer, Atypical Endometrial Hyperplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henri Azaïs, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Disorders and Fertility Issues, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of live births after embolisation (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05271981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.