Proliferative Effects of Erythropoietin on Human Endometrium

Study Overview
=================
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.

Official Title
-----------------
Proliferative Effects of Erythropoietin on Human Endometrium

Conditions
-----------------
Anemia, Endometrial Diseases

Intervention / Treatment
-----------------
* Drug: Erythropoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Erythropoietin<br>Recombinant Human Erythropoietin, EPREX 4000 IU/0.4 ml, three times in a week, until the correction of anemia, approximately two months. | Drug: Erythropoietin<br>* Recombinant Human Erythropoietin, three times in a week, until the correction of anemia, approximately two months.<br>* Other names: Recombinant Human Erythropoietin, EPREX 4000 IU/0.4 ml;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Endometrial Thickness Confirmed by Transvaginal Ultrasonography at 3th and 30th Days | Change from Baseline Endometrial Thickness Confirmed by Transvaginal | within the first 3 and 30 days (plus or minus 3 days) after the erythropoietin treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erythropoietin, Endometrium, Doppler Ultrasonography