Proliferative Effects of Erythropoietin on Human Endometrium

F

Fatih Sultan Mehmet Training and Research Hospital

Status

Completed

Conditions

Anemia
Endometrial Diseases

Treatments

Drug: Erythropoietin

Study type

Observational

Funder types

Other

Identifiers

NCT03060603
FSM EAH-KAEK 2016/7

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

14 participants in 1 patient group

Erythropoietin
Description:
Recombinant Human Erythropoietin, EPREX 4000 IU/0.4 ml, three times in a week, until the correction of anemia, approximately two months.
Treatment:
Drug: Erythropoietin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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