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Ulipristal Acetate 10 mg and Asisted Reproduction

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ClinicalTrials.gov Identifier: NCT02425878
Recruitment Status : Terminated (Lack of availibility of eligible subjects)
First Posted : April 24, 2015
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary:
Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks

Condition or disease Intervention/treatment Phase
Intramural Fibroids Uterine Fibroids Drug: Ulipristal Acetate Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Uterine Fibroids: Impact of Ulipristal Acetate 10 mg on ART Results
Actual Study Start Date : October 19, 2015
Actual Primary Completion Date : May 31, 2016
Actual Study Completion Date : May 31, 2016

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Arm Intervention/treatment
Experimental: Experimental
Ulipristal Acetate 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks
Drug: Ulipristal Acetate
Placebo Comparator: Control
Placebo, 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks
Drug: Placebo



Primary Outcome Measures :
  1. increase in the rate of clinical pregnancy [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425878


Locations
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Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
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Principal Investigator: Daniela Galliano, MDPhD Instituto Valenciano de Infertilidad, IVI VALENCIA
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Responsible Party: Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT02425878    
Other Study ID Numbers: 1311-BCN-138-DG
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Ulipristal acetate
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female