NCT03060603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 23, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2017

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

February 10, 2017

Last Update Submit

January 18, 2018

Conditions

AnemiaEndometrial Diseases

Keywords

ErythropoietinEndometriumDoppler Ultrasonography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

ErythropoietinDRUG

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

Also known as: Recombinant Human Erythropoietin, EPREX 4000 IU/0.4 ml
Erythropoietin

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from a tertiary research clinic, department of nephrology, Istanbul, Turkey.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Atasehir, 34758, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 19937447BACKGROUND

  • 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.

    PMID: 20884294BACKGROUND

  • 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.

    PMID: 25170305BACKGROUND

  • 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.

    PMID: 10995753BACKGROUND

  • 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.

    PMID: 11994541BACKGROUND

  • 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.

    PMID: 9738005RESULT

MeSH Terms

Conditions

AnemiaUterine Diseases

Interventions

ErythropoietinEpoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Niyazi Tug, Ass.Prof.

    Executive and Educational Supervisor

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 23, 2017

Study Start

February 23, 2017

Primary Completion

December 29, 2017

Study Completion

January 15, 2018

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)