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Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids (Lune2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577055
Recruitment Status : Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.


Condition or disease Intervention/treatment Phase
Leiomyoma Procedure: myomectomy Procedure: embolisation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids
Actual Study Start Date : April 2016
Actual Primary Completion Date : November 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids

Arm Intervention/treatment
Active Comparator: myomectomy
Women will be treated with surgical removal of all fibroids, either by laparoscopic or abdominal route
Procedure: myomectomy
Surgical ablation of all fibroids

Experimental: embolisation
Women will be treated with fertility sparing uterine arteries embolization (i..e. with ultra thin catheter, and particles' diameter > 500µm)
Procedure: embolisation
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 Name: Fertility sparing ultra selective uterine artery embolization




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577055


Locations
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France
Département de Médecine de la Reproduction, Centre Hospitalier Régionnal Universitaire de Montpellier
Montpellier, France, 34000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Antoine Torre, MD, PhD Faculté de médecine de Montpellier-Nîmes, Université de Montpellier 1, France.
Study Director: Arnaud Fauconnier, MD, PhD UFR des sciences de la santé Simone Veil, Université de Versailles Saint Quentin en Yvelines, France.
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02577055    
Other Study ID Numbers: P140311
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Leiomyoma
Uterine Artery Embolization
Surgery
childbearing age
Fertility
Noninferiority trial
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases