Esmya Versus Surgery Before IVF/ICSI
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|ClinicalTrials.gov Identifier: NCT04028986|
Recruitment Status : Active, not recruiting
First Posted : July 23, 2019
Last Update Posted : May 20, 2022
|Condition or disease||Intervention/treatment|
|Fibroid; Uterus Tumor, Complicating Pregnancy Infertility, Female Surgical Procedure, Unspecified||Drug: Ulipristal Acetate 5 MG Oral Tablet|
Uterine fibroids are the most common benign uterine tumors in women of reproductive age. Symptoms are depending on size, number and localisation of the fibroids. Heavy menstrual bleeding, anaemia, abdominal pain, dyspareunia and urinary symptoms are often put forward.
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:
- no treatment
medical pre-treatment before ART:
- with gonadotropin-releasing hormone (GnRH)-analogues followed by controlled ovarian stimulation
- with ESMYA followed by controlled ovarian stimulation
surgical treatment after medical pre-treatment before ART:
- after pre-treatment with GnRH analogues followed by myomectomy
- after ESMYA followed by myomectomy
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Efficacy of Ulipristalacetate in Comparison to Surgery Before IVF/ICSI-treatment in Women With Intramural Fibroids: Effect on Reproductive Outcome.|
|Actual Study Start Date :||January 1, 2016|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||June 1, 2023|
patients treated by surgery before starting the IVF/ICSI treatment
patients treated by ulipristalacetate before starting IVF/ICSI treatment
Drug: Ulipristal Acetate 5 MG Oral Tablet
use of ulipristalacetate OR surgery before fertility treatment
Other Name: surgery for fibroid
- ongoing pregnancy rates [ Time Frame: 2 years ]
- Miscarriage rate [ Time Frame: 2 years ]
- Time to pregnancy [ Time Frame: 2 years ]years
- Obstetric outcome described as live birth [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028986
|Universitair Ziekenhuis UZBrussel|
|Jette, Brussels, Belgium, 1090|