Esmya Versus Surgery Before IVF/ICSI

  • STATUS
    Recruiting
  • End date
    Jun 1, 2022
  • participants needed
    40
  • sponsor
    Universitair Ziekenhuis Brussel
Updated on 22 January 2021
body mass index
follicle stimulating hormone
endometriosis
fibroids
anti-mullerian hormone
in vitro fertilization
intracytoplasmic sperm injection

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:
  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.

Details
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

Eligibility

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
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
Clear my responses

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