Endometriosis OvariesNCT02984774
Assessment of Telomerase Activity in Endometrial Tissue and Serum in Endometriosis Patients
A study testing Cystectomy, Endometrial sampling and Peripheric blood sampling in people with Endometriosis Ovaries and Infertility, Female, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis Ovaries, Infertility, Female
- What is being tested?
- Cystectomy, Endometrial sampling and Peripheric blood sampling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis
Who cannot join
- Malign disorders Hormone replacement treatment Oral Contraceptive using
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nigar Sofiyeva
Istanbul, Non-US/Non-Canadian, 34098
About this study
Official title: Does Telomerase Activity Have an Effect on Infertility in Patients With Endometriosis ? Assessment of Telomerase Activity in Eutopic, Ectopic Endometrial Tissue and Serum
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.
Read the detailed description
Although distorted pelvic anatomy, impaired peritoneal, humoral and cellular functions, decreased implantation rate, oocyte and embryo quality, obstructed utero tubal connection are most researched aspects of endometriosis-related infertility, etiopathogenesis of endometriosis-related infertility still remains controversial.
Endometrial cell is a unique eukaryotic somatic cell with cyclic telomerase activity. Hormone-dependent cyclic variation of endometrial telomerase activity was stated in previous studies. On the other hand telomerase, activity was shown in endometriotic lesions, whereas this activity lacks in most of the somatic cells.
In this study, assessment of possible relation to increased telomerase activity in infertile patients with endometriosis was aimed.
Before published studies were assessed telomerase activity in benign and malign gynecological conditions and in endometriosis tissue, as well. But evaluation of ectopic and eutopic endometrial tissue and serum telomerase activity in infertile and fertile endometriosis and healthy control subjects was not performed.
Correlation of telomerase activity and endometriosis-related infertility was aimed in this study.
- Conditions
- Endometriosis Ovaries, Infertility, Female
- Being tested
- Cystectomy, Endometrial sampling, Peripheric blood sampling, Ovarian tissue sampling
- Keywords
- Endometriosis, Infertility, Telomerase activity
- Medical subject headings
- Infertility, Female, Endometriosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CystectomyProcedure or surgery
Segment of cystic wall from the patients for planned cystectomy was taken after operation and was preserved at -80º Celsius for further analysis
Endometrial samplingProcedure or surgery
Also called Pipelle endometrial suction curettage
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
Peripheric blood samplingProcedure or surgery
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
Ovarian tissue samplingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Infertile endometriosis | Experimental | Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia. Receives: 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. Receives: 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. Receives: Procedure: Endometrial sampling; Procedure: Peripheric blood sampling; Procedure: Ovarian tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomerase activity
Assessment of telomerase activity with Telomeric Repeat Amplification Protocol Polymerase Chain Reaction method from tissue and blood
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Age in years
From patient anamnesis
Measured: During admission to hospital for surgery
Marital status (single, married, divorced, widow)
From patient anamnesis
Measured: During admission to hospital for surgery
Smoking status ( yes/no)
From patient anamnesis
Measured: During admission to hospital for surgery
BMI in kg/m2
From patient anamnesis
Measured: During admission to hospital for surgery
Cystic size in cm
Macroscopically assessment during surgery
Measured: During operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startJun 2014
- Primary completionMar 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Endometriosis OvariesStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nigar Sofiyeva, Istanbul University
- Investigators
- Engin Oral, MD, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984774
- Sponsor's protocol ID
- 53684
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: General results is available for sharing.
Publications
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.
PubMed 6420199Bedaiwy 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.
PubMed 11821289Pizzo 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.
PubMed 12566749Lebovic DI, Mueller MD, Taylor RN. Immunobiology of endometriosis. Fertil Steril. 2001 Jan;75(1):1-10. doi: 10.1016/s0015-0282(00)01630-7.
PubMed 11163805Genbacev 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.
PubMed 12532021Cunha-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.
PubMed 12735387Kissler 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.
PubMed 16167942Tanaka 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.
PubMed 9846988Williams 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.
PubMed 11502832Kim 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.
PubMed 17077107Hapangama 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.
PubMed 18456668Lehner 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.
PubMed 11748987
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Telomerase Activity Have an Effect on Infertility in Patients With Endometriosis ? Assessment of Telomerase Activity in Eutopic, Ectopic Endometrial Tissue and Serum
- ClinicalTrials.gov ID
- NCT02984774
- Acronym / sponsor ID
- 53684
- Conditions
- Endometriosis Ovaries, Infertility, Female
- Keywords
- Endometriosis, Infertility, Telomerase activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although distorted pelvic anatomy, impaired peritoneal, humoral and cellular functions, decreased implantation rate, oocyte and embryo quality, obstructed utero tubal connection are most researched aspects of endometriosis-related infertility, etiopathogenesis of endometriosis-related infertility still remains controversial.
Endometrial cell is a unique eukaryotic somatic cell with cyclic telomerase activity. Hormone-dependent cyclic variation of endometrial telomerase activity was stated in previous studies. On the other hand telomerase, activity was shown in endometriotic lesions, whereas this activity lacks in most of the somatic cells.
In this study, assessment of possible relation to increased telomerase activity in infertile patients with endometriosis was aimed.
Before published studies were assessed telomerase activity in benign and malign gynecological conditions and in endometriosis tissue, as well. But evaluation of ectopic and eutopic endometrial tissue and serum telomerase activity in infertile and fertile endometriosis and healthy control subjects was not performed.
Correlation of telomerase activity and endometriosis-related infertility was aimed in this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infertile endometriosis | Experimental | Procedure: Cystectomy, Procedure: Endometrial sampling, Procedure: Peripheric blood samplingCystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia. |
| Fertile endometriosis | Experimental | Procedure: Cystectomy, Procedure: Endometrial sampling, Procedure: Peripheric blood samplingCystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia. |
| Control | Other | Procedure: Endometrial sampling, Procedure: Peripheric blood sampling, Procedure: Ovarian tissue samplingOvarian tissue sampling, endometrial sampling from hysterectomy and oophorectomy pieces and peripheric blood sampling during intravenous catheterization during anesthesia. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis
Key exclusion criteria (1 listed)
- Malign disorders Hormone replacement treatment Oral Contraceptive using
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CystectomySegment of cystic wall from the patients for planned cystectomy was taken after operation and was preserved at -80º Celsius for further analysis | Procedure or surgery | Fertile endometriosis, Infertile endometriosis |
| Endometrial samplingAlso: Pipelle endometrial suction curettageEndometrial sampling was performed at the same operation with the planned operation for the main indication and was preserved at -80º Celsius for further analysis | Procedure or surgery | Control, Fertile endometriosis, Infertile endometriosis |
| Peripheric blood sampling4 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 | Procedure or surgery | Control, Fertile endometriosis, Infertile endometriosis |
| Ovarian tissue sampling2cm 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 | Procedure or surgery | Control |
Primary outcome
Telomerase activity
Time frame: through study completion, an average of 1 year
Assessment of telomerase activity with Telomeric Repeat Amplification Protocol Polymerase Chain Reaction method from tissue and blood
5 secondary outcomes
Age in years
Time frame: During admission to hospital for surgery
Marital status (single, married, divorced, widow)
Time frame: During admission to hospital for surgery
Smoking status ( yes/no)
Time frame: During admission to hospital for surgery
BMI in kg/m2
Time frame: During admission to hospital for surgery
Cystic size in cm
Time frame: During operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Background: PubMed 6420199Schenken 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.
- Background: PubMed 11821289Bedaiwy 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.
- Background: PubMed 12566749Pizzo 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.
- Background: PubMed 11163805Lebovic DI, Mueller MD, Taylor RN. Immunobiology of endometriosis. Fertil Steril. 2001 Jan;75(1):1-10. doi: 10.1016/s0015-0282(00)01630-7.
- Background: PubMed 12532021Genbacev 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.
- Background: PubMed 12735387Cunha-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.
- Background: PubMed 16167942Kissler 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.
- Background: PubMed 9846988Tanaka 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.
- Background: PubMed 11502832Williams 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.
- Results publication: PubMed 17077107Kim 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.
- Results publication: PubMed 18456668Hapangama 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.
- Results publication: PubMed 11748987Lehner 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.
- Individual participant dataSharing planned: Undecided. General results is available for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Engin Oral, MD study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cystectomy, Endometrial sampling and Peripheric blood sampling in people with Endometriosis Ovaries and Infertility, Female, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomerase activity (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02984774, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.