No registrations found.
ID
Source
Brief title
Health condition
septate uterus
recurrent miscarriage
hysteroscopic metroplasty
metroplasty
uterine anomalies
uterus septum
uterusanomalieen
herhaalde miskraam
septumtranssectie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Live birth rate (defined as a live birth after 24 weeks of gestational age).
Secondary outcome
1. Complications following hysteroscopic metroplasty;
2. Obstetrical complications.
Background summary
It is recognized that the prevalence of the septate uterus is increased in women with recurrent
miscarriage and subfertility. At present the finding of a septate uterus in women with an active wish
to conceive is not an indication for surgical correction of the septum (metroplasty). It is questionable if metroplasty will improve reproductive outcome in these patients.
Objective: This study aims to answer the question whether hysteroscopic metroplasty will improve
reproductive outcome in women with recurrent miscarriage or subfertility and a septate uterus.
Study objective
Metroplasty in women with recurrent miscarriage or subfertility and a septate uterus will improve reproductive outcome.
Study design
No interim analysis has been planned.
Intervention
Hysteroscopic metroplasty.
Center for Reproductive Medicine<br>
Academic Medical Centre, the Netherlands
J.F.W. Rikken
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0) 6 23784797
trust@studies-obsgyn.nl
Center for Reproductive Medicine<br>
Academic Medical Centre, the Netherlands
J.F.W. Rikken
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0) 6 23784797
trust@studies-obsgyn.nl
Inclusion criteria
- Suspicion of a septate uterus
- Active wish to conceive
- (Recurrent) miscarriage, subfertility or preterm birth
- Diagnosis of a septate uterus
Exclusion criteria
1. Prior randomisation in the TRUST;
2. Contraindications for surgery.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1596 |
| NTR-old | NTR1676 |
| CCMO | NL24082.018.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
| OMON | NL-OMON37108 |