Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533907
• Other study ID #: 8/2018
• Status: Completed
• Start date: November 1, 2013
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Leiomyoma
• Myoma;Uterus

Locations

Country	Name	City	State
Italy	Paolo Emanuele Levi Setti	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implantation rate	number of intrauterine gestational sacs observed divided by the number of transferred embryos	2013 - 2018
Secondary	myomas reduction	volumetric reduction in after therapy	2013 - 2018