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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
Sponsor:
Information provided by (Responsible Party):
Dr. Eran Zilberberg, Sheba Medical Center

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.


Condition or disease Intervention/treatment Phase
Women With Leiomyoma After at Least One Unsuccessful IVF Treatment Drug: Ulipristal acetate Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Ongoing pregnancy [ Time Frame: About 10-12 weeks after embryo transfer ]
    Number of viable pregnancies at about 10-12 weeks of gestation

  2. Clinical pregnancy [ Time Frame: 3 weeks after embryo transfer ]
    Number of cases with gestational sac per US exam


Secondary Outcome Measures :
  1. Uterus size [ Time Frame: A month after the end of UPA treatment ]
    The size of the uterus per TVUS after UPA treatment

  2. 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)

  3. Number of oocytes retrieved [ Time Frame: Right after ovarian pick-up ]
    Number of oocytes retrieved during ovarian pick-up

  4. Number of embryos [ Time Frame: About 3 days after OPU (ovum pick-up) ]
    Number of developing embryos in the laboratory

  5. 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

  6. Live birth [ Time Frame: Until 40 weeks past embryo transfer ]
    Number of pregnancies ended in a live birth



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Publications:

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Responsible Party: Dr. Eran Zilberberg, Doctor, IVF unit, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02601196     History of Changes
Other Study ID Numbers: SHEBA-15-2101-EZ-CTIL
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Keywords provided by Dr. Eran Zilberberg, Sheba Medical Center:
Leiomyoma
Infertility
IVF
Ulipristal acetate
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Ulipristal acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs