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

NCT02601196 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-07-12

No results posted yet for this study

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.

Conditions

  • Women With Leiomyoma After at Least One Unsuccessful IVF Treatment

Interventions

DRUG

Ulipristal acetate

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.

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-01-31
Completion
2018-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601196 on ClinicalTrials.gov