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Angiogenesis in the endometrium of leiomyoma-related abnormal uterine bleeding.

The role of angiogenesis in the endometrium in the etiology of leiomyoma-related abnormal uterine bleeding: a prospective controlled in vitro studies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28541
Enrollment
60
Registered
2016-05-30
Start date
2015-12-15
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

• Leiomyoma, fibroids, myomen. • Abnormal uteriene bleeding (AUB), hevig menstrueel bloedverlies (HMB). • Angiogenesis, angiogenese.

Interventions

The patient will not undergo any specific interventions related to this study other than regular treatment for fibroids or heavy menstrual bleeding. Residual fibroid and endometrial tissue will be col

Sponsors

VU University Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Signed informed consent • > 18 years • Premenopausal • Myomectomy for bleeding disorders • Hysterectomy for bleeding disorders and fibroids • Hysterectomy for non-bleeding disorders (no fibroids)

Exclusion criteria

Exclusion criteria: • Uterine abnormalities (except fibroids) such as endometrial polyps and adenomyosis • deep infiltrating endometriosis, • pelvic inflammatory disease (PID), • previous occlusion or embolization of uterine vessels • malignancy of cervix, endometrium, myometrium or ovary

Design outcomes

Primary

MeasureTime frame
Histopathologic study: •Microvascular density (MVD), by the stained CD31/CD34. In vitro study •Time of recovery of HUVEC monolayer confluency, which gives a level of migration index. •Quantity of ATP present, equivalent to the presence of metabolically active HUVEC and consequently the degree of proliferation. •Motility index of HUVEC, which resembles the sprouting.

Secondary

MeasureTime frame
Histopathologic study: • Endothelial proliferation index, as ratio of expression of double stained CD31/CD34 and Ki-67. • The expression of actin (SMA positive vessels), which resemble the mature, pericyte covered vessels. • Difference in absolute number and percentage of pericyte-naked / immature vessels.

Contacts

Public ContactF.A. Groenman

VUMC. 8F-026

f.groenman@vumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)