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Clinical Trials in the EU / 2024-520166-63-00
Completed Phase III

Hysteroscopic resection versus medical management of early pregnancy loss (HyME): a randomized controlled trial

2024-520166-63-00 · tracked via the Priya Life Science EU tracker
Sponsor
UZ Brussel
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Female Urogenital Diseases and Pregnancy Complications
Decision date
26/11/2025
Enrollment target
152
Sites
Belgium

Condition studied

Early pregnancy loss (< 10 weeks of gestation)

Investigational medicinal product(s)

Mifegyne 200 mg comprimés - FRMifegyne 200 mg Tabletten - DECYTOTEC 200 microgrammescomprimés.Mifegyne 200 mg tabletten - NLCYTOTEC 200 microgram tabletten.Cytotec 200 Mikrogramm Tabletten

Eligibility

Age group
18-64 years
Sex
Female

Primary endpoint

Complete trophoblastic tissue expulsion, measured by the presence of a retained product of conception (RPOC) at ultrasound and diagnostic hysteroscopy ~1-2 month following intervention and the need for a secondary hysteroscopic resection

Endpoint detail

Intra-uterine adhesion rates at diagnostic hysteroscopy 1-2 months following complete evacuation, Pregnancy rates in the year following randomization, Rate of successful genetic analysis on the product of conception, Time needed to conceive, Complications occurring until 30 days post treatment, Patient well-being and quality of life evaluated by questionnaires 1-month and 3-months after the procedure

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-520166-63-00 on CTIS ↗ ← All trials in the EU