Overview

IVF Outcome Following Treatment With Ulipristal Acetate for Myomatous Uterus After at Least One IVF Failure

Status:
Unknown status
Trial end date:
2018-01-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sheba Medical Center
Treatments:
Ulipristal acetate
Criteria
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