Skip to main content
OpenTrials
Completed

NCT Number: NCT02577055

Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Montpellier, 34000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myomectomy

Procedure

Surgical ablation of all fibroids

embolisation

Procedure

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

Primary outcomes

  1. Number of live birth in a year of fertility attempt

    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.

Secondary outcomes

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

    Time frame: 18 months

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

    Time frame: 18 months

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

    Time frame: 18 months

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

    Time frame: 3 months

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

    Time frame: 6 months

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

    Time frame: 12 months

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

    Time frame: 18 months

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

    Time frame: 3 months

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

    Time frame: 6 months

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

    Time frame: 12 months

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

    Time frame: 18 months

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

    Time frame: Until 30 months

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

    Time frame: until 24 months

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

    Time frame: Until 30 months

  15. Number of adverse effects during pregnancy : foetal death

    Time frame: Until 30 months

  16. Number of adverse effects during pregnancy : uterine rupture

    Time frame: Until 30 months

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

    Time frame: Until 30 months

  18. Number of adverse effects during pregnancy : preterm delivery

    Time frame: Until 29 months

  19. Number of adverse effects during pregnancy : delivery hemorrhagy

    Time frame: Until 30 months

  20. number of adverse effects in the newborn

    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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: Lune2

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2015
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.