Proliferative Effects of Erythropoietin on Human Endometrium
Study Details
Study Description
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 | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | 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 Names:
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Outcome Measures
Primary Outcome Measures
- Change from Baseline Endometrial Thickness Confirmed by Transvaginal Ultrasonography at 3th and 30th Days [within the first 3 and 30 days (plus or minus 3 days) after the erythropoietin treatment]
Change from Baseline Endometrial Thickness Confirmed by Transvaginal
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinically condition with need for erythropoietin treatment such as anemia due to the renal failure or the need for hemodialysis.
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Must be in postmenopausal period
Exclusion Criteria:
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Patients with any type of malignancy
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Existence of any intracavitary mass which may affect endometrial thickness or blood flow such as endometrial polyps, myomas, intracavitary fluid etc.
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Intrauterine device
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Being on Hormon replacement therapy
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Hysterectomized patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- Study Chair: Niyazi Tug, Ass.Prof., Executive and Educational Supervisor
Study Documents (Full-Text)
None provided.More Information
Publications
- Ogilvie M, Yu X, Nicolas-Metral V, Pulido SM, Liu C, Ruegg UT, Noguchi CT. Erythropoietin stimulates proliferation and interferes with differentiation of myoblasts. J Biol Chem. 2000 Dec 15;275(50):39754-61.
- Tug N, Altunkaynak ME, Aktas RG, Kilic U, Yilmaz B, Cam C, Karateke A. Does erythropoietin affect motility of spermatozoa? Arch Gynecol Obstet. 2010 May;281(5):933-8. doi: 10.1007/s00404-009-1289-4. Epub 2009 Nov 25.
- Tug N, Kilic U, Karateke A, Yilmaz B, Ugur M, Kilic E. Erythropoietin receptor-like immunostaining on human spermatozoa. Reprod Biomed Online. 2010 Nov;21(5):718-20. doi: 10.1016/j.rbmo.2010.05.022. Epub 2010 Jun 19.
- Wang L, Di L, Noguchi CT. Erythropoietin, a novel versatile player regulating energy metabolism beyond the erythroid system. Int J Biol Sci. 2014 Aug 23;10(8):921-39. doi: 10.7150/ijbs.9518. eCollection 2014. Review.
- Yokomizo R, Matsuzaki S, Uehara S, Murakami T, Yaegashi N, Okamura K. Erythropoietin and erythropoietin receptor expression in human endometrium throughout the menstrual cycle. Mol Hum Reprod. 2002 May;8(5):441-6.
- FSM EAH-KAEK 2016/7