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Completed

NCT Number: NCT03060603

Proliferative Effects of Erythropoietin on Human Endometrium

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Atasehir, 34758, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythropoietin

Drug

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

Other names: Recombinant Human Erythropoietin, EPREX 4000 IU/0.4 ml

Primary outcomes

  1. Change from Baseline Endometrial Thickness Confirmed by Transvaginal Ultrasonography at 3th and 30th Days

    Time frame: within the first 3 and 30 days (plus or minus 3 days) after the erythropoietin treatment

    Change from Baseline Endometrial Thickness Confirmed by Transvaginal

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Collaborators

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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