Clinical trial NCT02577055: Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids
Official title: Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leiomyoma
Keywords: Leiomyoma
Uterine Artery Embolization
Surgery
childbearing age
Fertility
Noninferiority trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of live birth in a year of fertility attempt
timeFrame: 18 months
Secondary outcomes:
measure: number of adverse effects on fertility (ovarian reserve markers)
timeFrame: 18 months
measure: number of adverse effects on fertility (state of the uterine cavity)
timeFrame: 18 months
measure: number of adverse effects on fertility (state of the endometrium
timeFrame: 18 months
measure: Improvement of symptoms related to fibroids With UFS-QoL questionnaires
timeFrame: 3 months
measure: Improvement of symptoms related to fibroids With UFS-QoL questionnaires
timeFrame: 6 months
measure: Improvement of symptoms related to fibroids With UFS-QoL questionnaires
timeFrame: 12 months
measure: Improvement of symptoms related to fibroids With UFS-QoL questionnaires
timeFrame: 18 months
measure: Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
timeFrame: 3 months
measure: Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
timeFrame: 6 months
measure: Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
timeFrame: 12 months
measure: Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
timeFrame: 18 months
measure: Number of adverse effects during pregnancy : Rate of Miscarriage
timeFrame: Until 30 months
measure: Number of adverse effects during pregnancy : extra-uterine pregnancy
timeFrame: until 24 months
measure: Number of adverse effects during pregnancy : small for gestational age
timeFrame: Until 30 months
measure: Number of adverse effects during pregnancy : foetal death
timeFrame: Until 30 months
measure: Number of adverse effects during pregnancy : uterine rupture
timeFrame: Until 30 months
measure: Number of adverse effects during pregnancy : abnormal placental position and implantation
timeFrame: Until 30 months
measure: Number of adverse effects during pregnancy : preterm delivery
timeFrame: Until 29 months
measure: Number of adverse effects during pregnancy : delivery hemorrhagy
timeFrame: Until 30 months
measure: number of adverse effects in the newborn
timeFrame: At day 3 of life
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Département de Médecine de la Reproduction, Centre Hospitalier Régionnal Universitaire de Montpellier
Study officials:
affiliation: Faculté de médecine de Montpellier-Nîmes, Université de Montpellier 1, France.
name: Antoine Torre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UFR des sciences de la santé Simone Veil, Université de Versailles Saint Quentin en Yvelines, France.
name: Arnaud Fauconnier, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.