Assessment of Telomerase Activity in Endometrial Tissue and Serum in Endometriosis Patients

NCT02984774 | Completed

• 1 other identifier: 53684
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study was the detection of telomerase activity in eutopic, ectopic endometrial tissue and in peripheral blood and finding the correlation between the telomerase activity and clinic findings. With these results, confirmation of the hypothesis regarding the endometriosis pathogenesis and endometriosis-related infertility was aimed.

Conditions

Endometriosis Ovaries; Infertility, Female

Keywords

Endometriosis; Infertility; Telomerase activity

Outcome Measures

Primary Outcomes (1)

• Telomerase activity

  Assessment of telomerase activity with Telomeric Repeat Amplification Protocol Polymerase Chain Reaction method from tissue and blood

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Age in years

  During admission to hospital for surgery

• Marital status (single, married, divorced, widow)

  During admission to hospital for surgery

• Smoking status ( yes/no)

  During admission to hospital for surgery

• BMI in kg/m2

  During admission to hospital for surgery

• Cystic size in cm

  During operation

Study Arms (3)

Infertile endometriosis

EXPERIMENTAL

Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.

Procedure: Cystectomy; Procedure: Endometrial sampling; Procedure: Peripheric blood sampling

Fertile endometriosis

EXPERIMENTAL

Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.

Procedure: Cystectomy; Procedure: Endometrial sampling; Procedure: Peripheric blood sampling

Control

OTHER

Ovarian tissue sampling, endometrial sampling from hysterectomy and oophorectomy pieces and peripheric blood sampling during intravenous catheterization during anesthesia.

Procedure: Endometrial sampling; Procedure: Peripheric blood sampling; Procedure: Ovarian tissue sampling

Interventions

Cystectomy PROCEDURE

Segment of cystic wall from the patients for planned cystectomy was taken after operation and was preserved at -80º Celsius for further analysis

Fertile endometriosis; Infertile endometriosis

Endometrial sampling PROCEDURE

Endometrial sampling was performed at the same operation with the planned operation for the main indication and was preserved at -80º Celsius for further analysis

Also known as: Pipelle endometrial suction curettage

Control; Fertile endometriosis; Infertile endometriosis

Peripheric blood sampling PROCEDURE

4 cc peripheric venous blood was sampled into the EDTA(Ethylenediaminetetraacetic acid)-containing tubes during catheterization for anesthesia was preserved at 4º Celsius for further analysis

Control; Fertile endometriosis; Infertile endometriosis

Ovarian tissue sampling PROCEDURE

2cm linear tissue sample from ovarian cortex was performed at the same operation with the planned operation for the main indication and was preserved at -80º Celsius for further analysis

Control

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis

You may not qualify if:

• Malign disorders Hormone replacement treatment Oral Contraceptive using

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Nigar Sofiyeva

Istanbul, Non-US/Non-Canadian, 34098, Turkey (Türkiye)

Location

Related Publications (12)

• Schenken RS, Asch RH, Williams RF, Hodgen GD. Etiology of infertility in monkeys with endometriosis: luteinized unruptured follicles, luteal phase defects, pelvic adhesions, and spontaneous abortions. Fertil Steril. 1984 Jan;41(1):122-30. doi: 10.1016/s0015-0282(16)47552-7.

  PMID: 6420199 BACKGROUND

• Bedaiwy MA, Falcone T, Sharma RK, Goldberg JM, Attaran M, Nelson DR, Agarwal A. Prediction of endometriosis with serum and peritoneal fluid markers: a prospective controlled trial. Hum Reprod. 2002 Feb;17(2):426-31. doi: 10.1093/humrep/17.2.426.

  PMID: 11821289 BACKGROUND

• Pizzo A, Salmeri FM, Ardita FV, Sofo V, Tripepi M, Marsico S. Behaviour of cytokine levels in serum and peritoneal fluid of women with endometriosis. Gynecol Obstet Invest. 2002;54(2):82-7. doi: 10.1159/000067717.

  PMID: 12566749 BACKGROUND

• Lebovic DI, Mueller MD, Taylor RN. Immunobiology of endometriosis. Fertil Steril. 2001 Jan;75(1):1-10. doi: 10.1016/s0015-0282(00)01630-7.

  PMID: 11163805 BACKGROUND

• Genbacev OD, Prakobphol A, Foulk RA, Krtolica AR, Ilic D, Singer MS, Yang ZQ, Kiessling LL, Rosen SD, Fisher SJ. Trophoblast L-selectin-mediated adhesion at the maternal-fetal interface. Science. 2003 Jan 17;299(5605):405-8. doi: 10.1126/science.1079546.

  PMID: 12532021 BACKGROUND

• Cunha-Filho JS, Gross JL, Bastos de Souza CA, Lemos NA, Giugliani C, Freitas F, Passos EP. Physiopathological aspects of corpus luteum defect in infertile patients with mild/minimal endometriosis. J Assist Reprod Genet. 2003 Mar;20(3):117-21. doi: 10.1023/a:1022625106489.

  PMID: 12735387 BACKGROUND

• Kissler S, Hamscho N, Zangos S, Gatje R, Muller A, Rody A, Dobert N, Menzel C, Grunwald F, Siebzehnrubl E, Kaufmann M. Diminished pregnancy rates in endometriosis due to impaired uterotubal transport assessed by hysterosalpingoscintigraphy. BJOG. 2005 Oct;112(10):1391-6. doi: 10.1111/j.1471-0528.2005.00676.x.

  PMID: 16167942 BACKGROUND

• Tanaka M, Kyo S, Takakura M, Kanaya T, Sagawa T, Yamashita K, Okada Y, Hiyama E, Inoue M. Expression of telomerase activity in human endometrium is localized to epithelial glandular cells and regulated in a menstrual phase-dependent manner correlated with cell proliferation. Am J Pathol. 1998 Dec;153(6):1985-91. doi: 10.1016/S0002-9440(10)65712-4.

  PMID: 9846988 BACKGROUND

• Williams CD, Boggess JF, LaMarque LR, Meyer WR, Murray MJ, Fritz MA, Lessey BA. A prospective, randomized study of endometrial telomerase during the menstrual cycle. J Clin Endocrinol Metab. 2001 Aug;86(8):3912-7. doi: 10.1210/jcem.86.8.7729.

  PMID: 11502832 BACKGROUND

• Kim CM, Oh YJ, Cho SH, Chung DJ, Hwang JY, Park KH, Cho DJ, Choi YM, Lee BS. Increased telomerase activity and human telomerase reverse transcriptase mRNA expression in the endometrium of patients with endometriosis. Hum Reprod. 2007 Mar;22(3):843-9. doi: 10.1093/humrep/del425. Epub 2006 Oct 31.

  PMID: 17077107 RESULT

• Hapangama DK, Turner MA, Drury JA, Quenby S, Saretzki G, Martin-Ruiz C, Von Zglinicki T. Endometriosis is associated with aberrant endometrial expression of telomerase and increased telomere length. Hum Reprod. 2008 Jul;23(7):1511-9. doi: 10.1093/humrep/den172. Epub 2008 May 2.

  PMID: 18456668 RESULT

• Lehner R, Enomoto T, McGregor JA, Shroyer AL, Haugen BR, Pugazhenthi U, Shroyer KR. Quantitative analysis of telomerase hTERT mRNA and telomerase activity in endometrioid adenocarcinoma and in normal endometrium. Gynecol Oncol. 2002 Jan;84(1):120-5. doi: 10.1006/gyno.2001.6474.

  PMID: 11748987 RESULT

MeSH Terms

Conditions

Infertility, Female; Endometriosis; Infertility

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Engin Oral, MD

  Istanbul University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 7, 2016
• Study Start: June 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

TU (1)