Fertility After Myomectomy Versus Uterine Artery Embolization for

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Leiomyoma

Clinical Trial Details

NCT number	NCT02577055
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase	N/A
Start date	April 2016
Completion date	October 16, 2019

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids — Lune2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms