Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids

Conditions
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Leiomyoma

Intervention / Treatment
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* Procedure: myomectomy
* Procedure: embolisation


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: myomectomy<br>Women will be treated with surgical removal of all fibroids, either by laparoscopic or abdominal route | Procedure: myomectomy<br>* Surgical ablation of all fibroids<br>|
| Experimental: embolisation<br>Women will be treated with fertility sparing uterine arteries embolization (i..e. with ultra thin catheter, and particles' diameter > 500µm) | Procedure: embolisation<br>* 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.<br>* Other names: Fertility sparing ultra selective uterine artery embolization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of adverse effects on fertility (ovarian reserve markers) |  | 18 months | 
| number of adverse effects on fertility (state of the uterine cavity) |  | 18 months | 
| number of adverse effects on fertility (state of the endometrium |  | 18 months | 
| Improvement of symptoms related to fibroids With UFS-QoL questionnaires |  | 3 months | 
| Improvement of symptoms related to fibroids With UFS-QoL questionnaires |  | 6 months | 
| Improvement of symptoms related to fibroids With UFS-QoL questionnaires |  | 12 months | 
| Improvement of symptoms related to fibroids With UFS-QoL questionnaires |  | 18 months | 
| Quality of life With QSF questionnaires, a French version of the WHQ questionnaire |  | 3 months | 
| Quality of life With QSF questionnaires, a French version of the WHQ questionnaire |  | 6 months | 
| Quality of life With QSF questionnaires, a French version of the WHQ questionnaire |  | 12 months | 
| Quality of life With QSF questionnaires, a French version of the WHQ questionnaire |  | 18 months | 
| Number of adverse effects during pregnancy : Rate of Miscarriage |  | Until 30 months | 
| Number of adverse effects during pregnancy : extra-uterine pregnancy |  | until 24 months | 
| Number of adverse effects during pregnancy : small for gestational age |  | Until 30 months | 
| Number of adverse effects during pregnancy : foetal death |  | Until 30 months | 
| Number of adverse effects during pregnancy : uterine rupture |  | Until 30 months | 
| Number of adverse effects during pregnancy : abnormal placental position and implantation |  | Until 30 months | 
| Number of adverse effects during pregnancy : preterm delivery |  | Until 29 months | 
| Number of adverse effects during pregnancy : delivery hemorrhagy |  | Until 30 months | 
| 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) | At day 3 of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leiomyoma, Uterine Artery Embolization, Surgery, childbearing age, Fertility, Noninferiority trial