AzTrials
AzTrials

LeiomyomaLune2NCT02577055

Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids

A study testing myomectomy and embolisation in people with Leiomyoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 43 years, women only
Conditions the study is for
Leiomyoma
What is being tested?
myomectomy and embolisation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteFrance
Study dates
Apr 2016to 16 Oct 2019
Phase
Interventional
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 43 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Département de Médecine de la Reproduction, Centre Hospitalier Régionnal Universitaire de Montpellier

    Montpellier, 34000

Other trials in France

About this study

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.

Read the 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.
Conditions
Leiomyoma
Being tested
myomectomy, embolisation
Keywords
Leiomyoma, Uterine Artery Embolization, Surgery, childbearing age, Fertility, Noninferiority trial
Medical subject headings
Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • myomectomyProcedure or surgery

    Surgical ablation of all fibroids

  • embolisationProcedure or surgery

    Also called Fertility sparing ultra selective uterine artery embolization

    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.

Study groups in NCT02577055
Study groupRoleWhat they receive
myomectomyActive comparatorWomen will be treated with surgical removal of all fibroids, either by laparoscopic or abdominal route
Receives: Procedure: myomectomy
embolisationExperimentalWomen will be treated with fertility sparing uterine arteries embolization (i..e. with ultra thin catheter, and particles' diameter > 500µm)
Receives: Procedure: embolisation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 18 months

Secondary outcomes (20)

  1. number of adverse effects on fertility (ovarian reserve markers)

    Measured: 18 months

  2. number of adverse effects on fertility (state of the uterine cavity)

    Measured: 18 months

  3. number of adverse effects on fertility (state of the endometrium

    Measured: 18 months

  4. Improvement of symptoms related to fibroids With UFS-QoL questionnaires

    Measured: 3 months

  5. Improvement of symptoms related to fibroids With UFS-QoL questionnaires

    Measured: 6 months

  6. Improvement of symptoms related to fibroids With UFS-QoL questionnaires

    Measured: 12 months

  7. Improvement of symptoms related to fibroids With UFS-QoL questionnaires

    Measured: 18 months

  8. Quality of life With QSF questionnaires, a French version of the WHQ questionnaire

    Measured: 3 months

  9. Quality of life With QSF questionnaires, a French version of the WHQ questionnaire

    Measured: 6 months

  10. Quality of life With QSF questionnaires, a French version of the WHQ questionnaire

    Measured: 12 months

  11. Quality of life With QSF questionnaires, a French version of the WHQ questionnaire

    Measured: 18 months

  12. Number of adverse effects during pregnancy : Rate of Miscarriage

    Measured: Until 30 months

  13. Number of adverse effects during pregnancy : extra-uterine pregnancy

    Measured: until 24 months

  14. Number of adverse effects during pregnancy : small for gestational age

    Measured: Until 30 months

  15. Number of adverse effects during pregnancy : foetal death

    Measured: Until 30 months

  16. Number of adverse effects during pregnancy : uterine rupture

    Measured: Until 30 months

  17. Number of adverse effects during pregnancy : abnormal placental position and implantation

    Measured: Until 30 months

  18. Number of adverse effects during pregnancy : preterm delivery

    Measured: Until 29 months

  19. Number of adverse effects during pregnancy : delivery hemorrhagy

    Measured: Until 30 months

  20. 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)

    Measured: At day 3 of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2015 (estimated)
  2. Study startApr 2016
  3. Primary completion16 Oct 2019
  4. Study completion16 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02577055
Sponsor's protocol ID
P140311
Acronym
Lune2
Status last verified
Oct 2025
First submitted
20 Jul 2015
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2012 May 16;(5):CD005073. doi: 10.1002/14651858.CD005073.pub3.

    PubMed 22592701

  • Torre A, Paillusson B, Fain V, Labauge P, Pelage JP, Fauconnier A. Uterine artery embolization for severe symptomatic fibroids: effects on fertility and symptoms. Hum Reprod. 2014 Mar;29(3):490-501. doi: 10.1093/humrep/det459. Epub 2014 Jan 15.

    PubMed 24430777

  • Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85. doi: 10.1007/s00270-007-9195-2. Epub 2007 Oct 18.

    PubMed 17943348

Questions about this trial

What is this clinical trial studying?

A study testing myomectomy and embolisation in people with Leiomyoma, 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 6 inclusion and 3 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 20 Nov 2025. 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?

Number of live birth in a year of fertility attempt (time frame: 18 months). 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 NCT02577055, which also lists 3 linked publications.

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 20 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in