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Proliferative Effects of Erythropoietin on Human Endometrium

Proliferative Effects of Erythropoietin on Human Endometrium

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03060603
Enrollment
14
Registered
2017-02-23
Start date
2017-02-23
Completion date
2018-01-15
Last updated
2018-01-23

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

Conditions

Anemia, Endometrial Diseases

Keywords

Erythropoietin, Endometrium, Doppler Ultrasonography

Brief summary

The purpose of this study to assess the proliferative effects of erythropoetin on human endometrium tissue by measuring the endometrial thickness, uterine artery and subendometrial blood flow in postmenopausal women.

Detailed description

20 postmenopausal women who are planned to treat with erythropoietin alpha for their renal conditions will be included to the study. Sample size was calculated with proper power analysis with accepting the difference of 1 mm in endometrial thickness as a significant change. After the informed consent, endometrial thickness (mm), uterine artery and subendometrial blood flow by doppler ultrasonography (RI, S/D) will be measured. Same measurements will be repeated on the 3rd day and 30th day. Patients' age, BMI, co-morbidities, administered erythropoietin doses will be noted. No adverse effect is expected with regard to the ultrasonographic examination. Date of the patients who do not attend for the appointments for repetitive examinations and uninterpretable doppler variables due to the atrophic uterus will be noted as the missing data and will be excluded from the study. Proper statistical analysis will be done.

Interventions

DRUGErythropoietin

Recombinant Human Erythropoietin, three times in a week, until the correction of anemia, approximately two months.

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital
CollaboratorOTHER_GOV
Fatih Sultan Mehmet Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Clinically condition with need for erythropoietin treatment such as anemia due to the renal failure or the need for hemodialysis. * Must be in postmenopausal period

Exclusion criteria

* Patients with any type of malignancy * Existence of any intracavitary mass which may affect endometrial thickness or blood flow such as endometrial polyps, myomas, intracavitary fluid etc. * Intrauterine device * Being on Hormon replacement therapy * Hysterectomized patients

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Endometrial Thickness Confirmed by Transvaginal Ultrasonography at 3th and 30th Dayswithin the first 3 and 30 days (plus or minus 3 days) after the erythropoietin treatmentChange from Baseline Endometrial Thickness Confirmed by Transvaginal

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026