Skip to content

Esmya Versus Surgery Before IVF/ICSI

Efficacy of Ulipristalacetate in Comparison to Surgery Before IVF/ICSI-treatment in Women With Intramural Fibroids: Effect on Reproductive Outcome.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04028986
Enrollment
40
Registered
2019-07-23
Start date
2016-01-01
Completion date
2026-06-01
Last updated
2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibroid; Uterus Tumor, Complicating Pregnancy, Infertility, Female, Surgical Procedure, Unspecified

Keywords

ulipristalacetate, fertility treatment, IVF/ICSI, fibroid

Brief summary

Studying the possible outcome differences between surgery or medical treatment with ulipristalacetate (UPA) solely before 'in-vitro fertilisation/intracytoplasmic sperm injection' (IVF/ICSI) treatment in infertile couples.

Detailed description

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: 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.

Interventions

DRUGUlipristal Acetate 5 MG Oral Tablet

use of ulipristalacetate OR surgery before fertility treatment

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No

Inclusion criteria

* 1st, 2nd or 3th IVF/ICSI attempt * 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

* More than 2 submucous fibroids * Poor responders * Severe male factor

Design outcomes

Primary

MeasureTime frame
ongoing pregnancy rates2 years

Secondary

MeasureTime frameDescription
Miscarriage rate2 years
Time to pregnancy2 yearsyears
Obstetric outcome described as live birth2 years

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026