terine fibroids: Impact of ulipristal acetate 10 mg on ART results

Phase 1

• Conditions: terine Fibroids and Assisted Reproduction; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2014-000964-16-ES
• Lead Sponsor: IVI Valencia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-04
• Study Completion: 2016-05-31
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• 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 again
BMI 18-30 kg/m2
Informed consent signed and dated
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 282
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: Check ifthere are significant differences in the proportions of evolutionary gestation rate of clinical and biochemical abortions and ectopic pregnancy rate due to treatment with Ulpristal. <br>Assess volume reduction / fibroid (pre and post tto) for 3D / 3D ultrasound measuring 2D. <br>Assess the change in the levels of E2, P4 and FSH (pre and post tto) <br>Rate the change in pain reported by the patients in the study with VAS (pre and post tto) <br>Assess and record the most common side effects of Esmya (see Side Effects section).;Primary end point(s): Evolutionary gestation;Timepoint(s) of evaluation of this end point: Patients will be recruited for a year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): biochemical pregnancy <br>clinical pregnancy <br>Implantation rate <br>ectopic pregnancy <br>Abortion biochemical <br>Abortion clinic;Timepoint(s) of evaluation of this end point: Patients will be recruited for a year