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Randomized Controlled Trial
. 2023 Feb;160(2):492-501.
doi: 10.1002/ijgo.14626.

Effects on heavy menstrual bleeding and pregnancy of uterine artery embolization (UAE) or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: The FEMME randomized controlled trial

Fusun Sirkeci  1 , John Moss  2 , Anna M Belli  3 , Klim McPherson  4 , Jane Daniels  5 , Isaac Manyonda  6 , Lee Middleton  7 , Versha Cheed  7 , Olivia Wu  8 , Mary A Lumsden  2 ; FEMME Trial Collaborative Group
Affiliations
Randomized Controlled Trial

Effects on heavy menstrual bleeding and pregnancy of uterine artery embolization (UAE) or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: The FEMME randomized controlled trial

Fusun Sirkeci et al. Int J Gynaecol Obstet. 2023 Feb.

Abstract

Objective: To determine treatment options (myomectomy vs. uterine artery embolization (UAE)) for women wishing to avoid hysterectomy.

Methods: A multicenter randomized controlled trial was conducted on 254 women and data were collected on fibroid-specific quality of life (UFS-QOL), loss of menstrual blood, and pregnancy.

Results: At 4 years, the mean difference in the UFS-QOL was 5.0 points (95% confidence interval (CI) -1.4 to 11.5; P = 0.13) in favor of myomectomy. This was not statistically significant as it was at 2 years. There were no differences in bleeding scores, rates of amenorrhea, or heavy bleeding. Of those who were still menstruating, the majority reported regular or fairly regular periods: 36 of 48 (75%) in the UAE group and 30 of 39 (77%) in the myomectomy group. Twelve women after UAE and six women after myomectomy became pregnant (4 years) with seven and five live births, respectively (hazard ratio 0.48, 95% CI 0.18-1.28). There was no difference between the levels of hormones associated with the uterine reserve in each group.

Conclusion: Leiomyoma are common in reproductive-aged women, causing heavy menses and subfertility. Among women with uterine fibroids, myomectomy resulted in better fibroid-related quality of life at 4 years, compared with UAE but the treatments decreased menstrual bleeding equally. There was also no significant difference in the impact of treatment on ovarian reserve.

Keywords: United Kingdom; female; myomectomy; ovarian reserve; pregnancy rate; quality of life; uterine artery embolization; uterine fibroid.

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Conflict of interest statement

MAL reports personal fees from Gedeon Richter outside the submitted work (2018). All other authors declare they have no competing interests. All authors have completed the unified competing interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare (1) no financial support for the submitted work from anyone other than their employer; (2) no financial relationships with commercial entities that might have an interest in the submitted work; (3) no spouses, partners, or children with relationships to commercial entities that might have an interest in the submitted work; and (4) no non‐financial interests that may be relevant to the submitted work.

Figures

FIGURE 1
FIGURE 1
Flow of participants through the FEMME trial up to 2 years of follow‐up. LTFU, lost to follow‐up; UAE, uterine artery embolization; UFS‐QOL, Uterine Fibroid Symptom Quality of Life.
FIGURE 2
FIGURE 2
Kaplan–Meier plot of time to achieve pregnancy in the two groups who were followed up beyond the end of the study to 4 years. It indicates that numbers overall were low over that time. The numbers in the UAE group continued to rise. UAE, uterine artery embolization.
See this image and copyright information in PMC

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