Ulipristal Acetate 10 mg and Asisted Reproduction

Phase 3

Terminated

• Conditions: Intramural Fibroids; Uterine Fibroids
• Interventions: Drug: Placebo; Drug: Ulipristal Acetate

• Registration Number: NCT02425878
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-24
• Study Start: 2015-10-19
• Primary Completion: 2016-05-31
• Study Completion: 2016-05-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Placebo, 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks
Experimental	Ulipristal Acetate	Ulipristal Acetate 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks

Primary Outcome Measures

Name	Time	Method
increase in the rate of clinical pregnancy	12 weeks

Trial Locations

Locations (1)

IVI Valencia; 🇪🇸 Valencia, Spain