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Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.

Sponsor
Istituto Clinico Humanitas (Other)
Overall Status
Completed
CT.gov ID
NCT03533907
Collaborator
(none)
20
Enrollment
1
Location
53.9
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators analyzed a group of infertile women treated with Ulipristal Acetate (UA) for uterine fibroids at the Humanitas Fertility Center. All the patients' data were extracted from the Fertility Center external-audit-anonymized electronic research query system.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In the recent years several large studies have been published on the efficacy of Ulipristal

    Acetate treatment of moderate to severe symptoms of uterine fibroids in adult women:

    initially proposed only as pre-surgical treatment, the UA was subsequently also used for the long-term treatment of uterine myomas symptoms.

    However, few data are available on the effects of UA in terms of increasing fecundability, implantation and pregnancy outcome and safety in the general population, and in infertile patients in particular.

    This retrospective study aims at describing the correlation between the use of Ulipristal Acetate and pregnancy outcome in infertile patients and at comparing the UA plus surgery approach to the UA-only treatment in terms of pregnancy outcome.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate: Preliminary Academic Assisted Reproductive Technology Center Experience.
    Actual Study Start Date :
    Nov 1, 2013
    Actual Primary Completion Date :
    Apr 10, 2018
    Actual Study Completion Date :
    May 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    treated

    The women included were patients of the Humanitas Fertility Center; they all had a diagnosis of infertility and were trying to become pregnant. They received ≥1 month of therapy with UA 5 mg/day

    Outcome Measures

    Primary Outcome Measures

    1. implantation rate [2013 - 2018]

      number of intrauterine gestational sacs observed divided by the number of transferred embryos

    Secondary Outcome Measures

    1. myomas reduction [2013 - 2018]

      volumetric reduction in after therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • infertile women received at least 1 month of therapy with UA 5 mg/day for uterine fibroids

    • more of 1 year of active pregnancy seeking

    Exclusion:
    • menopausal women;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Paolo Emanuele Levi Setti Rozzano MI Italy 20089

    Sponsors and Collaborators

    • Istituto Clinico Humanitas

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Clinico Humanitas
    ClinicalTrials.gov Identifier:
    NCT03533907
    Other Study ID Numbers:
    • 8/2018
    First Posted:
    May 23, 2018
    Last Update Posted:
    Jun 8, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Infertility
    Infertility, Female

    Study Results

    No Results Posted as of Jun 8, 2018