Trial reportActa obstetricia et gynecologica Scandinavica2020
Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Short-term results of a double-blind randomized controlled trial.
Trial report in Acta obstetricia et gynecologica Scandinavica, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Preoperative medical therapy before surgery for uterine fibroids.The Cochrane database of systematic reviews · 2025Pooled it
- What happens after randomised controlled trials? Uterine fibroids and ulipristal acetate: systematic review and meta-analysis of "real-world" data.Archives of gynecology and obstetrics · 2021Pooled it
- Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Short-term results of a double-blind randomized controlled trial.Acta obstetricia et gynecologica Scandinavica · 2020Trial
- The estrogen-progestogen-oxidative stress network in uterine fibroids: mechanistic insights and therapeutic opportunities.Redox report : communications in free radical research · 2026Review
- Progesterone signaling in uterine fibroids: Molecular mechanisms and therapeutic opportunities.Life sciences · 2025Review
- Mismatch of populations between randomised controlled trials of perioperative interventions in major abdominal surgery and current clinical practice.Perioperative medicine (London, England) · 2023Review
- Laparoscopic myomectomy - The importance of surgical techniques.Frontiers in medicine · 2023Review
- Myomectomy in infertile women: More harm than good?Frontiers in surgery · 2023Review
- Effect of medical treatments in disseminated peritoneal leiomyomatosis: a case report.Journal of surgical case reports · 2022Article
- Evaluation of marketing authorization and clinical implementation of ulipristal acetate for uterine fibroids.Human reproduction (Oxford, England) · 2022Review
- Efficacy of Laparoscopic Surgery Combined With Leuprorelin in the Treatment of Endometriosis Associated With Infertility and Analysis of Influencing Factors for Recurrence.Frontiers in surgery · 2022Article
- Risk-efficacy balance of ulipristal acetate compared to surgical alternatives.British journal of clinical pharmacology · 2021Review
- 90 YEARS OF PROGESTERONE: Selective progesterone receptor modulators in gynaecological therapies.Journal of molecular endocrinology · 2020Review
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Authors and funding
9 authors at 6 institutions in 1 country.
Funding
Abstract
introductionLaparoscopic myomectomy can be difficult when fibroids are large and numerous. This may result in extensive intraoperative bleeding and the need for a conversion to a laparotomy. Medical pretreatment prior to surgery might reduce these risks by decreasing fibroid size and vascularization of the fibroid. We compared pretreatment with ulipristal acetate (UPA) vs gonadotropin-releasing hormone agonists (GnRHa) prior to laparoscopic myomectomy on several intra- and postoperative outcomes. MATERIAL AND
methodsWe performed a non-inferiority double-blind randomized controlled trial in nine hospitals in the Netherlands. Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks. The primary outcome was intraoperative blood loss. Secondary outcomes were reduction of fibroid volume, suturing time, total surgery time and surgical ease.
resultsThirty women received UPA and 25 women leuprolide acetate. Non-inferiority of UPA regarding intraoperative blood loss was not demonstrated. When pretreated with UPA, median intraoperative blood loss was statistically significantly higher (525 mL [348-1025] vs 280 mL[100-500]; P = 0.011) and suturing time of the first fibroid was statistically significantly longer (40 minutes [28-48] vs 22 minutes [14-33]; P = 0.003) compared with GnRHa. Pretreatment with UPA showed smaller reduction in fibroid volume preoperatively compared with GnRHa (-7.2% [-35.5 to 54.1] vs -38.4% [-71.5 to -19.3]; P = 0.001). Laparoscopic myomectomies in women pretreated with UPA were subjectively judged more difficult than in women pretreated with GnRHa.
conclusionsNon-inferiority of UPA in terms of intraoperative blood loss could not be established, possibly due to the preliminary termination of the study. Pretreatment with GnRHa was more favorable than UPA in terms of fibroid volume reduction, intraoperative blood loss, hemoglobin drop directly postoperatively, suturing time of the first fibroid and several subjective surgical ease parameters.
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