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Ulipristal Acetate 10 mg and Asisted Reproduction

Primary Purpose

Intramural Fibroids, Uterine Fibroids

Status

Terminated

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Ulipristal Acetate

Placebo

About this trial

This is an interventional treatment trial for Intramural Fibroids

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

IVI Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

increase in the rate of clinical pregnancy

Secondary Outcome Measures

Full Information

NCT ID

NCT02425878

First Posted

April 21, 2015

Last Updated

October 13, 2020

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

1. Study Identification

Unique Protocol Identification Number

NCT02425878

Brief Title

Ulipristal Acetate 10 mg and Asisted Reproduction

Official Title

Uterine Fibroids: Impact of Ulipristal Acetate 10 mg on ART Results

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Terminated

Why Stopped

Lack of availibility of eligible subjects

Study Start Date

October 19, 2015 (Actual)

Primary Completion Date

May 31, 2016 (Actual)

Study Completion Date

May 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intramural Fibroids, Uterine Fibroids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ulipristal Acetate

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

increase in the rate of clinical pregnancy

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniela Galliano, MDPhD

Organizational Affiliation

Instituto Valenciano de Infertilidad, IVI VALENCIA

Official's Role

Principal Investigator

Facility Information:

Facility Name

IVI Valencia

City

Valencia

ZIP/Postal Code

46015

Country

Spain

12. IPD Sharing Statement

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Ulipristal Acetate 10 mg and Asisted Reproduction

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