NCT02601196

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

October 15, 2015

Last Update Submit

July 10, 2016

Conditions

Women With Leiomyoma After at Least One Unsuccessful IVF Treatment

Keywords

LeiomyomaInfertilityIVFUlipristal acetate

Outcome Measures

Primary Outcomes (2)

  • Ongoing pregnancy

    Number of viable pregnancies at about 10-12 weeks of gestation

    About 10-12 weeks after embryo transfer

  • Clinical pregnancy

    Number of cases with gestational sac per US exam

    3 weeks after embryo transfer

Secondary Outcomes (6)

  • Uterus size

    A month after the end of UPA treatment

  • Fibroids status

    A month after the end of UPA treatment

  • Number of oocytes retrieved

    Right after ovarian pick-up

  • Number of embryos

    About 3 days after OPU (ovum pick-up)

  • Number of top quality embryos

    3 days after OPU

  • +1 more secondary outcomes

Study Arms (1)

Ulipristal acetate treatment

OTHER

Women who receive UPA treatment before another IVF cycle.

Drug: Ulipristal acetate

Interventions

Ulipristal acetateDRUG

Transvaginal US and diagnostic hysteroscopy - to ascertain suitability. A therapeutic course of ulipristal acetate 5 mg per day for 13 weeks. After completion of the treatment protocol - another TVUS, diagnostic hysteroscopy and histological examination of the endometrium - to assess results of UPA treatment. Another IVF cycle.

Ulipristal acetate treatment

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Intolerance for UPA treatment
  • Fibroids distorting the uterine cavity
  • Poor responder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Klatsky 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: 18395031BACKGROUND

  • Pritts 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: 18339376BACKGROUND

  • Casini 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: 16603437BACKGROUND

  • Sunkara 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: 19910322BACKGROUND

  • Donnez 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: 22296075BACKGROUND

  • Donnez 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: 22296076BACKGROUND

  • Luyckx 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.

    PMID: 25241376BACKGROUND

  • Bernard N, Elefant E, Carlier P, Tebacher M, Barjhoux CE, Bos-Thompson MA, Amar E, Descotes J, Vial T. Continuation of pregnancy after first-trimester exposure to mifepristone: an observational prospective study. BJOG. 2013 Apr;120(5):568-74. doi: 10.1111/1471-0528.12147. Epub 2013 Jan 24.

    PMID: 23346916BACKGROUND

  • Gemzell-Danielsson K, Rabe T, Cheng L. Emergency contraception. Gynecol Endocrinol. 2013 Mar;29 Suppl 1:1-14. doi: 10.3109/09513590.2013.774591.

    PMID: 23437846BACKGROUND

  • Williams AR, Bergeron C, Barlow DH, Ferenczy A. Endometrial morphology after treatment of uterine fibroids with the selective progesterone receptor modulator, ulipristal acetate. Int J Gynecol Pathol. 2012 Nov;31(6):556-69. doi: 10.1097/PGP.0b013e318251035b.

    PMID: 23018219BACKGROUND

MeSH Terms

Conditions

LeiomyomaInfertility

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGenital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, IVF unit

Study Record Dates

First Submitted

October 15, 2015

First Posted

November 10, 2015

Study Start

September 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 12, 2016

Record last verified: 2016-07