Proliferative Effects of Erythropoietin on Human Endometrium

Anemia Clinical Trial

Official title:

Proliferative Effects of Erythropoietin on Human Endometrium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060603
• Other study ID #: FSM EAH-KAEK 2016/7
• Status: Completed
• Phase: N/A
• First received: February 10, 2017
• Last updated: January 18, 2018
• Start date: February 23, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: January 2018
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 15, 2018
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Endometrial Diseases
• Uterine Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Fatih Sultan Mehmet Training and Research Hospital	Istanbul	Atasehir

Sponsors (2)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital	Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yasuda Y, Masuda S, Chikuma M, Inoue K, Nagao M, Sasaki R. Estrogen-dependent production of erythropoietin in uterus and its implication in uterine angiogenesis. J Biol Chem. 1998 Sep 25;273(39):25381-7. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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