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

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Leiomyoma

Treatments

Procedure: embolisation

Procedure: myomectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02577055

P140311

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

Female

Ages

18 to 43 years old

Volunteers

No Healthy Volunteers

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