Clinical trial · Observational
Esmya Versus Surgery Before IVF/ICSI
Efficacy of Ulipristalacetate in Comparison to Surgery Before IVF/ICSI-treatment in Women With Intramural Fibroids: Effect on Reproductive Outcome.
NCT04028986CI-TRIAL-00066467unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroid; Uterus Tumor, Complicating Pregnancy | — | UNRESOLVED | — |
| Infertility, Female | — | UNRESOLVED | — |
| Surgical Procedure, Unspecified | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ulipristal Acetate 5 MG Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Surgery group
- description
- patients treated by surgery before starting the IVF/ICSI treatment
- label
- Ulipristalacetate group
- description
- patients treated by ulipristalacetate before starting IVF/ICSI treatment
- interventionNames
- Drug: Ulipristal Acetate 5 MG Oral Tablet
Primary outcomes (1)
- measure
- ongoing pregnancy rates
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Miscarriage rate
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 38 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.