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Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.

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ClinicalTrials.gov Identifier: NCT03533907
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Study Description
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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
Myoma;Uterus Infertility, Female

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
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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 : November 1, 2013
Actual Primary Completion Date : April 10, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. implantation rate [ Time Frame: 2013 - 2018 ]
    number of intrauterine gestational sacs observed divided by the number of transferred embryos


Secondary Outcome Measures :
  1. myomas reduction [ Time Frame: 2013 - 2018 ]
    volumetric reduction in after therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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 over the period 2013 - 2018
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533907


Locations
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Italy
Paolo Emanuele Levi Setti
Rozzano, MI, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
More Information
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Publications of Results:

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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03533907    
Other Study ID Numbers: 8/2018
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Infertility
Infertility, Female
Neoplasms, Muscle Tissue
 Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases