Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
40 participants
OBSERVATIONAL
2016-01-01
2026-06-01
Brief Summary
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Detailed Description
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Intramural and especially submucous myomas are known to decrease fertility and augment miscarriage rate. Some studies have demonstrated a negative effect of intramural fibroids on fertility outcome, while others do not. A recent meta-analysis found adverse pregnancy outcomes associated not only with submucous and intramural fibroids distorting the uterine cavity, but also with intramural fibroids not distorting the cavity.
Ulipristalacetate (Esmya®) is currently used to pre-treat symptomatic women with fibroids before surgical intervention. Esmya® has been demonstrated to be safe and effective in the treatment of fibroids. Due to apoptosis sometimes a reduction in volume of the myoma is seen. This effect could influence the fertility and operative outcome.
Current options are available before assisted reproductive technology (ART) for infertile women diagnosed with fibroids:
1. no treatment
2. medical pre-treatment before ART:
1. with gonadotropin-releasing hormone (GnRH)-analogues followed by controlled ovarian stimulation
2. with ESMYA followed by controlled ovarian stimulation
3. surgical treatment after medical pre-treatment before ART:
1. after pre-treatment with GnRH analogues followed by myomectomy
2. after ESMYA followed by myomectomy
4. surgical treatment without medical pre-treatment
In our tertiary infertility centre, at the discretion of the physician, as well ESMYA treatment solely or surgery before starting an IVF/ICSI treatment in women with intramural fibroids are often used. Is there a difference in ongoing pregnancy rate after IVF/ICSI in these patients?
Objective of the study Prospective and retrospective gathering of information regarding the efficacy of IVF/ICSI treatment (ongoing pregnancy rates) in patients undergoing medical or surgical treatment preceding their IVF/ICSI treatment in case of diagnosis of intramural fibroids. Especially ongoing pregnancy rates between patients receiving the ESMYA solely treatment and patients pre-treated by myomectomy before IVF/ICSI will be studied once sufficient data have been collected to deduce valuable study results.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Surgery group
patients treated by surgery before starting the IVF/ICSI treatment
No interventions assigned to this group
Ulipristalacetate group
patients treated by ulipristalacetate before starting IVF/ICSI treatment
Ulipristal Acetate 5 MG Oral Tablet
use of ulipristalacetate OR surgery before fertility treatment
Interventions
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Ulipristal Acetate 5 MG Oral Tablet
use of ulipristalacetate OR surgery before fertility treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* infertility Indications:
* unexplained
* tubal
* male/donor sperm
* endometriosis I/II
* Body Mass Index (BMI) \>18 - \< 30
* Basal Follicle Stimulating Hormone (FSH) \< 10 IU/L
* anti-mullerian hormone (AMH) \> 1 ng/ml
* Normal ultrasound apart from the following:
* Type 2 fibroid : ≤2cm diameter
* Type 3 - 5 fibroids: with diameter ≥ 3 and ≤10cm according to classification of European Society for Gynecological Endoscopy (ESGE )
Exclusion Criteria
* Poor responders
* Severe male factor
18 Years
38 Years
FEMALE
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Stefan Cosyns
Principal Investigator
Locations
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Universitair Ziekenhuis UZBrussel
Jette, Brussels Capital, Belgium
Countries
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Other Identifiers
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B.U.N.14320152
Identifier Type: -
Identifier Source: org_study_id
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