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

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520166-63-00
Enrollment
152
Registered
2025-11-26
Start date
2025-12-18
Completion date
Unknown
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early pregnancy loss (< 10 weeks of gestation)

Brief summary

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

Detailed description

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

Interventions

DRUGMifegyne 200 mg comprimés - FR
DRUGMifegyne 200 mg Tabletten - DE
DRUGCYTOTEC 200 microgrammes
DRUGcomprimés.
DRUGMifegyne 200 mg tabletten - NL
DRUGCYTOTEC 200 microgram tabletten.
DRUGCytotec 200 Mikrogramm Tabletten

Sponsors

UZ Brussel
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026