Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.

Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate: Preliminary Academic Assisted Reproductive Technology Center Experience.

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female; Myoma;Uterus

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Paolo Emanuele Levi Setti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implantation rate	number of intrauterine gestational sacs observed divided by the number of transferred embryos	2013 - 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
myomas reduction	volumetric reduction in after therapy	2013 - 2018

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Publications and helpful links

General Publications

• Luyckx M, Squifflet JL, Jadoul P, Votino R, Dolmans MM, Donnez J. First series of 18 pregnancies after ulipristal acetate treatment for uterine fibroids. Fertil Steril. 2014 Nov;102(5):1404-9. doi: 10.1016/j.fertnstert.2014.07.1253. Epub 2014 Sep 17.
• Donnez J, Donnez O, Matule D, Ahrendt HJ, Hudecek R, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Loumaye E. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril. 2016 Jan;105(1):165-173.e4. doi: 10.1016/j.fertnstert.2015.09.032. Epub 2015 Oct 23.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2013
• Primary Completion (ACTUAL): April 10, 2018
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (ACTUAL): May 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Infertility; Infertility, Female; Leiomyoma; Myofibroma
• Other Study ID Numbers: 8/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No