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The role of endometrial angiogenesis in patients with bleeding disorders in case of submucous fibroids

The role of endometrial angiogenesis in patients with bleeding disorders in case of submucous fibroids - Endometrial Angiogenesis related to fibroids.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36239
Enrollment
50
Registered
2011-08-02
Start date
2012-02-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Fibroid leiomyomata

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Premenopausal women, aged above18 years, with a regular menstrual cycle planned for a transcervical hysteroscopic resection (TCRM) of submucous fibroids.

Exclusion criteria

Exclusion criteria: Occlusion or embolization of uterine arteries in the history, risk of pelvic inflammatory disease, known endometrioses, cervical cancer or pregnancy.

Design outcomes

Primary

MeasureTime frame
Differences in histological vascular density (based on CD34/31) in endometrium covering fibroids versus normal endometrium.

Secondary

MeasureTime frame
Differenes in kwantified VEGF-A, VEGF-B, VEGF-C, FGF, Estradiol receptor, Progesterone receptor expression, kwantified hysteroscopic vascular density (using Narrow Band Imaging). Level of CD34/31 related ki67 expression. The relation between endometrial vascularity index and angiogenic profile in endometrium covering a fibroid with severity of menstrual bleeding (PBAC) and total number of days will be assessed. Potential prognostic parameters: age, cycle day, OC or GnRHa use, fibroid size and level of protrusion (GIS) and vascular indices measured with 3D TV-US will be registered.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)