Esmya Versus Surgery Before IVF/ICSI

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04028986
• Other study ID #: B.U.N.14320152
• Status: Active, not recruiting
• Start date: January 1, 2016
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ulipristal Acetate 5 MG Oral Tablet
use of ulipristalacetate OR surgery before fertility treatment

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis UZBrussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ongoing pregnancy rates		2 years
Secondary	Miscarriage rate		2 years
Secondary	Time to pregnancy	years	2 years
Secondary	Obstetric outcome described as live birth		2 years