Clinical trial NCT04028986: Esmya Versus Surgery Before IVF/ICSI
Official title: Efficacy of Ulipristalacetate in Comparison to Surgery Before IVF/ICSI-treatment in Women With Intramural Fibroids: Effect on Reproductive Outcome.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fibroid; Uterus Tumor, Complicating Pregnancy
Infertility, Female
Surgical Procedure, Unspecified
Keywords: ulipristalacetate
fertility treatment
IVF/ICSI
fibroid
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: females with fibroids and infertility

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.

Eligibility criteria: 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

Primary outcomes:
measure: ongoing pregnancy rates
timeFrame: 2 years
Secondary outcomes:
measure: Miscarriage rate
timeFrame: 2 years
measure: Time to pregnancy
timeFrame: 2 years
measure: Obstetric outcome described as live birth
timeFrame: 2 years
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis UZBrussel
state: Brussels
Study officials:
References: