Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-01

Study Completion Date

2018-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myoma;Uterus Infertility, Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No