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Proliferative Effects of Erythropoietin on Human Endometrium

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ClinicalTrials.gov Identifier: NCT03060603
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Information provided by (Responsible Party):
MEHMET AKIF SARGIN, Fatih Sultan Mehmet Training and Research Hospital

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.

Condition or disease Intervention/treatment
Anemia Endometrial Diseases Drug: Erythropoietin

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.

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proliferative Effects of Erythropoietin on Human Endometrium
Actual Study Start Date : February 23, 2017
Actual Primary Completion Date : December 29, 2017
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort Intervention/treatment
Erythropoietin
Recombinant Human Erythropoietin, EPREX 4000 IU/0.4 ml, three times in a week, until the correction of anemia, approximately two months.
Drug: Erythropoietin
Recombinant Human Erythropoietin, three times in a week, until the correction of anemia, approximately two months.
Other Name: Recombinant Human Erythropoietin, EPREX 4000 IU/0.4 ml




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from a tertiary research clinic, department of nephrology, Istanbul, Turkey.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060603


Locations
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Turkey
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Atasehir, Turkey, 34758
Sponsors and Collaborators
Fatih Sultan Mehmet Training and Research Hospital
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Investigators
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Study Chair: Niyazi Tug, Ass.Prof. Executive and Educational Supervisor

Publications of Results:
Other Publications:
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Responsible Party: MEHMET AKIF SARGIN, Principal Investigator, Fatih Sultan Mehmet Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03060603     History of Changes
Other Study ID Numbers: FSM EAH-KAEK 2016/7
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by MEHMET AKIF SARGIN, Fatih Sultan Mehmet Training and Research Hospital:
Erythropoietin
Endometrium
Doppler Ultrasonography
Additional relevant MeSH terms:
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Uterine Diseases
Genital Diseases, Female
Epoetin Alfa
Hematinics