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Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.

Completed
Conditions
Myoma;Uterus
Infertility, Female
Registration Number
NCT03533907
Lead Sponsor
Istituto Clinico Humanitas
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
20
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;
Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
implantation rate2013 - 2018

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

Secondary Outcome Measures
NameTimeMethod
myomas reduction2013 - 2018

volumetric reduction in after therapy

Trial Locations

Locations (1)

Paolo Emanuele Levi Setti

🇮🇹

Rozzano, MI, Italy

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