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

Start 18 Dec 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)

Status Ongoing, recruiting

Participants planned 152

Countries 1

Sites 1

Early pregnancy loss (< 10 weeks of gestation)

The aim of this trial is to compare primary hysteroscopic resection versus medical management of early miscarriages (< 10 weeks of gestation) in terms of efficacy, short and long-term complications, reproductive outcomes and patient satisfaction.

Key facts

Sponsor: UZ Brussel
Participant type: Patients
Age range: 18-64 years
Gender: Female
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration: 18 Dec 2025 → ongoing
Decision date (initial): 2025-11-26
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy

Secondary objectives 1

To evaluate the presence of intra-uterine adhesions at follow-up hysteroscopy.

Conditions and MedDRA coding

Early pregnancy loss (< 10 weeks of gestation)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

EPL < 10 weeks of gestation
Age ≥18 ≤ 50 years
Signed informed consent

Exclusion criteria 5

Pregnancy of unknown location
Severe bleeding requiring immediate surgical intervention
Previous history of uterine surgery without proof of a normal cavity following the procedure
Contra-indication to medical treatment including: Women who present with hemorrhage, hemodynamic instability, or signs of infection, Adrenal insufficiency, severe asthma.
Women with severe anemia, bleeding disorders, or cardiovascular disease.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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 endpoints 6

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Mifegyne 200 mg Tabletten - DE

PRD11591306 · Product

Active substance: Mifepristone
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: G03XB01 — MIFEPRISTONE
Marketing authorisation: BE207487
MA holder: EXELGYN SA
MA country: Belgium
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mifegyne 200 mg comprimés - FR

PRD8663397 · Product

Active substance: Mifepristone
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: G03XB01 — MIFEPRISTONE
Marketing authorisation: BE207487
MA holder: EXELGYN SA
MA country: Belgium
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CYTOTEC 200 microgram tabletten.

PRD2076571 · Product

Active substance: Misoprostol
Pharmaceutical form: TABLET
Route of administration: VAGINAL USE
Max daily dose: 800 µg microgram(s)
Max total dose: 800 µg microgram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: A02BB01 — MISOPROSTOL
Marketing authorisation: BE134093
MA holder: PFIZER S.A.
MA country: Belgium
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CYTOTEC 200 microgrammes, comprimés.

PRD2076608 · Product

Active substance: Misoprostol
Pharmaceutical form: TABLET
Route of administration: VAGINAL USE
Max daily dose: 800 µg microgram(s)
Max total dose: 800 µg microgram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: A02BB01 — MISOPROSTOL
Marketing authorisation: BE134093
MA holder: PFIZER S.A.
MA country: Belgium
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mifegyne 200 mg tabletten - NL

PRD9870451 · Product

Active substance: Mifepristone
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: G03XB01 — MIFEPRISTONE
Marketing authorisation: BE207487
MA holder: EXELGYN SA
MA country: Belgium
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cytotec 200 Mikrogramm Tabletten

PRD2076614 · Product

Active substance: Misoprostol
Pharmaceutical form: TABLET
Route of administration: VAGINAL USE
Max daily dose: 800 µg microgram(s)
Max total dose: 800 µg microgram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: A02BB01 — MISOPROSTOL
Marketing authorisation: BE134093
MA holder: PFIZER S.A.
MA country: Belgium
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Brussel

Sponsor organisation: UZ Brussel
Address: Laarbeeklaan 101
City: Jette
Postcode: 1090
Country: Belgium

Scientific contact point

Organisation: UZ Brussel
Contact name: Michelle Soares

Public contact point

Organisation: UZ Brussel
Contact name: Elsie Nulens

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruiting	152	1
Rest of world	—	0	—

Investigational sites

Belgium

1 site · Ongoing, recruiting

UZ Brussel

Brussels IVF, Laarbeeklaan 101, 1090, Jette

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Belgium	2025-12-18		2026-03-11

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 36 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol 2024-520166-63-00_redacted	2
Protocol (for publication)	D4_Patient facing documents_Annex 2 EN	1
Protocol (for publication)	D4_Patient facing documents_Annex 2 FR	1
Protocol (for publication)	D4_Patient facing documents_Annex 2 NL	1
Protocol (for publication)	D4_Patient facing documents_Annex 3 EN	1
Protocol (for publication)	D4_Patient facing documents_Annex 3 FR	1
Protocol (for publication)	D4_Patient facing documents_Annex 3 NL	1
Protocol (for publication)	D4_Patient facing documents_Annex 4 EN	1
Protocol (for publication)	D4_Patient facing documents_Annex 4 FR	1
Protocol (for publication)	D4_Patient facing documents_Annex 4 NL	1
Protocol (for publication)	D4_Patient facing documents_Annex 5 EN redacted	1.3
Protocol (for publication)	D4_Patient facing documents_Annex 5 FR redacted	1.2
Protocol (for publication)	D4_Patient facing documents_Annex 5 NL redacted	1.1
Protocol (for publication)	D4_Patient facing documents_Annex 7 EN	1
Protocol (for publication)	D4_Patient facing documents_Annex 7 FR	1
Protocol (for publication)	D4_Patient facing documents_Annex 7 NL	1
Protocol (for publication)	D4_Surgeon facing documents_Annex 1 EN	1
Protocol (for publication)	D4_Surgeon facing documents_Annex 1 FR	1
Protocol (for publication)	D4_Surgeon facing documents_Annex 1 NL	1
Protocol (for publication)	D4_Surgeon facing documents_Annex 6 EN	1
Protocol (for publication)	D4_Surgeon facing documents_Annex 6 FR	1
Protocol (for publication)	D4_Surgeon facing documents_Annex 6 NL	1
Recruitment arrangements (for publication)	K1_Recruitment and Informed consent procedure	1
Subject information and informed consent form (for publication)	L1_SIS and ICF NON RANDOMIZED EN redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF NON RANDOMIZED FR redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF NON RANDOMIZED NL redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF RANDOMIZED EN redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF RANDOMIZED FR redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF RANDOMIZED NL redacted	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Cytotec FR	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Cytotec NL	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Mifegyne FR	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Mifegyne NL	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis DE 2024-520166-63-00_redacted	2
Synopsis of the protocol (for publication)	D1_Protocol synopsis FR 2024-520166-63-00_redacted	2
Synopsis of the protocol (for publication)	D1_Protocol synopsis NL 2024-520166-63-00_redacted	2

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-09-17	Belgium	Acceptable 2025-11-19	2025-11-26