Status:
ACTIVE_NOT_RECRUITING
Esmya Versus Surgery Before IVF/ICSI
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Fibroid; Uterus Tumor, Complicating Pregnancy
Infertility, Female
Eligibility:
FEMALE
18-38 years
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...
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, abd...
Eligibility Criteria
Inclusion
- 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
- More than 2 submucous fibroids
- Poor responders
- Severe male factor
Key Trial Info
Start Date :
January 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04028986
Start Date
January 1 2016
End Date
June 1 2026
Last Update
May 16 2023
Active Locations (1)
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1
Universitair Ziekenhuis UZBrussel
Jette, Brussels Capital, Belgium, 1090