Infertility, Female Clinical Trial
Official title:
Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate: Preliminary Academic Assisted Reproductive Technology Center Experience.
NCT number | NCT03533907 |
Other study ID # | 8/2018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2013 |
Est. completion date | May 1, 2018 |
Verified date | May 2018 |
Source | Istituto Clinico Humanitas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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; |
Country | Name | City | State |
---|---|---|---|
Italy | Paolo Emanuele Levi Setti | Rozzano | MI |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
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
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 |
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