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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02425878 |
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Date of registration:
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21/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ulipristal Acetate 10 mg and Asisted Reproduction
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Scientific title:
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Uterine Fibroids: Impact of Ulipristal Acetate 10 mg on ART Results |
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Date of first enrolment:
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October 19, 2015 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02425878 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Spain
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Contacts
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Name:
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Daniela Galliano, MDPhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Valenciano de Infertilidad, IVI VALENCIA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients> 18 and <50 years Patients who undergo a first / second cycle OVD Patients who
present within 1-3 intramural myomas> 2 cm and <5 cm that do not distort the cavity, Type 3
and 4 of the FIGO classification (Figure 1). Miomas inoperable for medical judgment or
patient desire, you want to avoid the post-surgical time waiting 6 months / 1 year before
you can submit to TRA Patients who have undergone previous myomectomy who prefer to avoid
having surgery
Exclusion Criteria:
History of endometrial changes in patients (hyperplasia) Presence of other endometrial
pathologies: polyps, scars of previous cesarean complicated adenomyosis foci, suspected
adhesions Simultaneous participation in another clinical study
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Intramural Fibroids
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Uterine Fibroids
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Intervention(s)
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Drug: Placebo
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Drug: Ulipristal Acetate
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Primary Outcome(s)
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increase in the rate of clinical pregnancy
[Time Frame: 12 weeks]
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Secondary ID(s)
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1311-BCN-138-DG
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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