Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.

Istituto Clinico Humanitas

Status: Completed

Conditions: Myoma;Uterus; Infertility, Female

Study type: Observational

Funder types: Other

Identifiers

NCT03533907

8/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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;

Trial design

20 participants in 1 patient group

treated

Description:

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