Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids

Leiomyoma Clinical Trial

— Lune2  

Official title:

Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577055
• Other study ID #: P140311
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 16, 2019

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 16, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma

Intervention

Procedure:
• myomectomy
Surgical ablation of all fibroids
• 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.

Locations

Country	Name	City	State
France	Département de Médecine de la Reproduction, Centre Hospitalier Régionnal Universitaire de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

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. Review. Update in: Cochrane Database Syst Rev. 2014;(12):CD005073. — View 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. Epub 2007 Oct 18. — View 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. — View Citation

Outcome

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