Esmya Versus Surgery Before IVF/ICSI

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04028986

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibroid; Uterus Tumor, Complicating Pregnancy Infertility, Female Surgical Procedure, Unspecified	Drug: Ulipristal Acetate 5 MG Oral Tablet

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:

no treatment
medical pre-treatment before ART:
with gonadotropin-releasing hormone (GnRH)-analogues followed by controlled ovarian stimulation
with ESMYA followed by controlled ovarian stimulation
surgical treatment after medical pre-treatment before ART:
after pre-treatment with GnRH analogues followed by myomectomy
after ESMYA followed by myomectomy
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Surgery group patients treated by surgery before starting the IVF/ICSI treatment
Ulipristalacetate group patients treated by ulipristalacetate before starting IVF/ICSI treatment	Drug: Ulipristal Acetate 5 MG Oral Tablet use of ulipristalacetate OR surgery before fertility treatment Other Names: surgery for fibroid

Arm

Intervention/Treatment

Surgery group

patients treated by surgery before starting the IVF/ICSI treatment

Ulipristalacetate group

patients treated by ulipristalacetate before starting IVF/ICSI treatment

Drug: Ulipristal Acetate 5 MG Oral Tablet

use of ulipristalacetate OR surgery before fertility treatment

Other Names:

surgery for fibroid

Outcome Measures

Primary Outcome Measures

ongoing pregnancy rates [2 years]

Secondary Outcome Measures

Miscarriage rate [2 years]
Time to pregnancy [2 years]
years
Obstetric outcome described as live birth [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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 )