Clinical trial NCT03060603: Proliferative Effects of Erythropoietin on Human Endometrium
Official title: Proliferative Effects of Erythropoietin on Human Endometrium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Endometrial Diseases
Keywords: Erythropoietin
Endometrium
Doppler Ultrasonography
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Dr. Lutfi Kirdar Kartal Training and Research Hospital
First posted: 2017-02-23
Enrollment: 14
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from a tertiary research clinic, department of nephrology, Istanbul, Turkey.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline Endometrial Thickness Confirmed by Transvaginal Ultrasonography at 3th and 30th Days
timeFrame: within the first 3 and 30 days (plus or minus 3 days) after the erythropoietin treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatih Sultan Mehmet Training and Research Hospital
state: Atasehir
Study officials:
affiliation: Executive and Educational Supervisor
name: Niyazi Tug, Ass.Prof.
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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. doi: 10.1074/jbc.M004999200.
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. doi: 10.1093/molehr/8.5.441.
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. doi: 10.1074/jbc.273.39.25381.