Clinical trial · Interventional
IVF Outcome Following Treatment With Ulipristal Acetate for Myomatous Uterus After at Least One IVF Failure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hypothesis: After reviewing the relevant medical data the investigators assume that treating a woman with intramural fibroid not distorting the uterine cavity or mostly intramural with less than 50% submucosal component with Ulipristal Acetate (UPA) for a 13 weeks course would reduce the fibroid size and improve her chance for conceiving by IVF treatment. Materials \& Methods: Study design: A proof of concept prospective not randomized study. The patients: About 20 women treated in the fertility and IVF unit after at least one IVF failure, with mostly intramural (IM) fibroid \[class 2-5 by FIGO (International Federation of Gynecology and Obstetrics) classification system\] in the size of \>4 cm confirmed by Transvaginal ultrasound (TVUS) and diagnostic hysteroscopy. After US examination and diagnostic hysteroscopy to ascertain suitability for this study, the investigators will offer a course of 13 weeks treatment with UPA 5 mg per day. One month after cessation of treatment the investigators will perform another TVUS examination \& diagnostic hysteroscopy plus endometrial biopsy in order to assess the endometrial \& uterine status and will conduct an additional IVF cycle, using the same stimulation protocol undertaken during the immediate cycle previous to the UPA treatment course.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Women With Leiomyoma After at Least One Unsuccessful IVF Treatment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ulipristal acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Ulipristal acetate treatment
- description
- Women who receive UPA treatment before another IVF cycle.
- interventionNames
- Drug: Ulipristal acetate
Primary outcomes (2)
- measure
- Ongoing pregnancy
- timeFrame
- About 10-12 weeks after embryo transfer
- description
- Number of viable pregnancies at about 10-12 weeks of gestation
- measure
- Clinical pregnancy
- timeFrame
- 3 weeks after embryo transfer
- description
- Number of cases with gestational sac per US exam
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 44 Years
Show eligibility criteria text
Inclusion Criteria: * Infertile women in the age of 18-44 years * At least after one failure in IVF treatment * Normal responders (more than 3 oocytes retrieved in previous controlled ovarian hyperstimulation treatment). * Intramural fibroid between 4-10 cm, not distorting the uterine cavity Exclusion Criteria: * Intolerance for UPA treatment * Fibroids distorting the uterine cavity * Poor responder
References
Publications (10)
- BACKGROUNDKlatsky PC, Tran ND, Caughey AB, Fujimoto VY. Fibroids and reproductive outcomes: a systematic literature review from conception to delivery. Am J Obstet Gynecol. 2008 Apr;198(4):357-66. doi: 10.1016/j.ajog.2007.12.039. PMID 18395031
- BACKGROUNDPritts EA, Parker WH, Olive DL. Fibroids and infertility: an updated systematic review of the evidence. Fertil Steril. 2009 Apr;91(4):1215-23. doi: 10.1016/j.fertnstert.2008.01.051. Epub 2008 Mar 12. PMID 18339376
- BACKGROUNDCasini ML, Rossi F, Agostini R, Unfer V. Effects of the position of fibroids on fertility. Gynecol Endocrinol. 2006 Feb;22(2):106-9. doi: 10.1080/09513590600604673. PMID 16603437
- BACKGROUNDSunkara SK, Khairy M, El-Toukhy T, Khalaf Y, Coomarasamy A. The effect of intramural fibroids without uterine cavity involvement on the outcome of IVF treatment: a systematic review and meta-analysis. Hum Reprod. 2010 Feb;25(2):418-29. doi: 10.1093/humrep/dep396. Epub 2009 Nov 12. PMID 19910322
- BACKGROUNDDonnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF, Ivanova T, Ugocsai G, Mara M, Jilla MP, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012 Feb 2;366(5):409-20. doi: 10.1056/NEJMoa1103182. PMID 22296075
- BACKGROUNDDonnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180. PMID 22296076
- BACKGROUNDLuyckx M, Squifflet JL, Jadoul P, Votino R, Dolmans MM, Donnez J. First series of 18 pregnancies after ulipristal acetate treatment for uterine fibroids. Fertil Steril. 2014 Nov;102(5):1404-9. doi: 10.1016/j.fertnstert.2014.07.1253. Epub 2014 Sep 17.