Proliferative Effects of Erythropoietin on Human Endometrium

NCT ID: NCT03060603

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-23

Study Completion Date

2018-01-15

Brief Summary

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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

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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.

Conditions

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Anemia Endometrial Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Erythropoietin

Recombinant Human Erythropoietin, EPREX 4000 IU/0.4 ml, three times in a week, until the correction of anemia, approximately two months.

Erythropoietin

Intervention Type DRUG

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

Interventions

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Erythropoietin

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

Intervention Type DRUG

Other Intervention Names

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Recombinant Human Erythropoietin, EPREX 4000 IU/0.4 ml

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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MEHMET AKIF SARGIN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niyazi Tug, Ass.Prof.

Role: STUDY_CHAIR

Executive and Educational Supervisor

Locations

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Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Atasehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 19937447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20884294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25170305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10995753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11994541 (View on PubMed)

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.

Reference Type RESULT
PMID: 9738005 (View on PubMed)

Other Identifiers

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FSM EAH-KAEK 2016/7

Identifier Type: -

Identifier Source: org_study_id

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