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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 April 2021 |
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Main ID: |
NCT02577055 |
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Date of registration:
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20/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids
Lune2 |
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Scientific title:
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Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02577055 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Arnaud Fauconnier, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UFR des sciences de la santé Simone Veil, Université de Versailles Saint Quentin en Yvelines, France. |
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Name:
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Antoine Torre, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculté de médecine de Montpellier-Nîmes, Université de Montpellier 1, France. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
43 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Leiomyoma
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Intervention(s)
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Procedure: myomectomy
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Procedure: embolisation
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Primary Outcome(s)
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Number of live birth in a year of fertility attempt
[Time Frame: 18 months]
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Secondary Outcome(s)
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Number of adverse effects during pregnancy : uterine rupture
[Time Frame: Until 30 months]
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number of adverse effects in the newborn
[Time Frame: At day 3 of life]
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number of adverse effects on fertility (state of the endometrium
[Time Frame: 18 months]
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Number of adverse effects during pregnancy : abnormal placental position and implantation
[Time Frame: Until 30 months]
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Number of adverse effects during pregnancy : extra-uterine pregnancy
[Time Frame: until 24 months]
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Number of adverse effects during pregnancy : Rate of Miscarriage
[Time Frame: Until 30 months]
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Improvement of symptoms related to fibroids With UFS-QoL questionnaires
[Time Frame: 3 months]
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Number of adverse effects during pregnancy : preterm delivery
[Time Frame: Until 29 months]
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Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
[Time Frame: 3 months]
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Improvement of symptoms related to fibroids With UFS-QoL questionnaires
[Time Frame: 12 months]
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Improvement of symptoms related to fibroids With UFS-QoL questionnaires
[Time Frame: 18 months]
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Improvement of symptoms related to fibroids With UFS-QoL questionnaires
[Time Frame: 6 months]
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number of adverse effects on fertility (ovarian reserve markers)
[Time Frame: 18 months]
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Number of adverse effects during pregnancy : delivery hemorrhagy
[Time Frame: Until 30 months]
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Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
[Time Frame: 12 months]
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Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
[Time Frame: 18 months]
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Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
[Time Frame: 6 months]
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Number of adverse effects during pregnancy : foetal death
[Time Frame: Until 30 months]
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Number of adverse effects during pregnancy : small for gestational age
[Time Frame: Until 30 months]
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number of adverse effects on fertility (state of the uterine cavity)
[Time Frame: 18 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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