IVF Outcome Following Treatment With Ulipristal Acetate for Myomatous Uterus After at Least One IVF Failure
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|ClinicalTrials.gov Identifier: NCT02601196|
Recruitment Status : Unknown
Verified July 2016 by Dr. Eran Zilberberg, Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : November 10, 2015
Last Update Posted : July 12, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Women With Leiomyoma After at Least One Unsuccessful IVF Treatment||Drug: Ulipristal acetate||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||IVF Outcome Following Treatment With Ulipristal Acetate for Myomatous Uterus After at Least One IVF Failure|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Ulipristal acetate treatment
Women who receive UPA treatment before another IVF cycle.
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.
- Ongoing pregnancy [ Time Frame: About 10-12 weeks after embryo transfer ]Number of viable pregnancies at about 10-12 weeks of gestation
- Clinical pregnancy [ Time Frame: 3 weeks after embryo transfer ]Number of cases with gestational sac per US exam
- Uterus size [ Time Frame: A month after the end of UPA treatment ]The size of the uterus per TVUS after UPA treatment
- Fibroids status [ Time Frame: A month after the end of UPA treatment ]Status of fibroids per TVUS after UPA treatment (number, location, volume cm^3)
- Number of oocytes retrieved [ Time Frame: Right after ovarian pick-up ]Number of oocytes retrieved during ovarian pick-up
- Number of embryos [ Time Frame: About 3 days after OPU (ovum pick-up) ]Number of developing embryos in the laboratory
- Number of top quality embryos [ Time Frame: 3 days after OPU ]The number of day 3 embryos with 7-8 cells with less than 15% fragmentation
- Live birth [ Time Frame: Until 40 weeks past embryo transfer ]Number of pregnancies ended in a live birth