Esmya Versus Surgery Before IVF/ICSI

  • End date
    Jun 1, 2022
  • participants needed
  • sponsor
    Universitair Ziekenhuis Brussel
Updated on 22 January 2021
body mass index
follicle stimulating hormone
anti-mullerian hormone
in vitro fertilization
intracytoplasmic sperm injection


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.


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:
  3. with gonadotropin-releasing hormone (GnRH)-analogues followed by controlled ovarian stimulation
  4. with ESMYA followed by controlled ovarian stimulation
  5. surgical treatment after medical pre-treatment before ART:
  6. after pre-treatment with GnRH analogues followed by myomectomy
  7. after ESMYA followed by myomectomy
  8. 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.

Condition Female infertility, Fibroid; Uterus Tumor, Complicating Pregnancy, Surgical Procedure, Unspecified, Fibroid; Uterus Tumor, Complicating Pregnancy, Surgical Procedure, Unspecified, Fibroid; Uterus Tumor, Complicating Pregnancy, Surgical Procedure, Unspecified
Treatment Ulipristal Acetate 5 MG Oral Tablet
Clinical Study IdentifierNCT04028986
SponsorUniversitair Ziekenhuis Brussel
Last Modified on22 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 38 yrs?
Are you female?
Do you have any of these conditions: Fibroid; Uterus Tumor, Complicating Pregnancy or Female infertility or Surgical Procedure, Unspecified?
st, 2nd or 3th IVF/ICSI attempt
infertility Indications
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note