Skip to content

Comparative, controlled trial of treatment of minor uterine cavity abnormalities diagnosed by office hysteroscopy screening in women indicated for IVF.

Comparative, controlled trial of treatment of minor uterine cavity abnormalities diagnosed by office hysteroscopy screening in women indicated for IVF. - Treatment Efficacy of uterine Abnormalities (TEA) trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30448
Enrollment
200
Registered
2007-02-19
Start date
2007-06-28
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

uterine cavity abnormalities

Interventions

Office Hysteroscopy procedure Hysteroscopy will be performed under supervision of the same investigating team (FB and MK) on an outpatient basis under paracervical block using in total 10 ml Xylocai

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Normal Transvaginal Ultrasound - No prior hysteroscopy - Age

Exclusion criteria

Exclusion criteria: - Recurrent miscarriage - Prior hysteroscopic treatments - Endometriosis >= AFS Stage III - Meno-metrorrhagia (defined as any intermenstrual loss of blood) - Submucosal/Intracavitary Fibroids taking more than 50% of the cavity - Hydrosalpinx - FSH/ LH > 12 IU/L on day 3 - Polyps taking more than 50 % of the cavity

Design outcomes

Primary

MeasureTime frame
The main study parameters are: Uterine cavity condition 1. Normal cavity (including uterus arcuatus), or 2. Predefined Cavitary Abnormality: - Partial septum (

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)