Ulipristal Acetate 10 mg and Asisted Reproduction

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status and phase: Terminated; Phase 3

Conditions: Uterine Fibroids; Intramural Fibroids

Treatments: Drug: Placebo; Drug: Ulipristal Acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT02425878

1311-BCN-138-DG

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Ulipristal Acetate 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks

Treatment:

Drug: Ulipristal Acetate

Control

Placebo Comparator group

Description:

Placebo, 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks

Treatment:

Drug: Placebo