Ovarian Reserve, Endometrioma, PTEN-AKT-FOXO3 Gene ExpressionNCT04058912
PTEN-AKT-FOXO3 Gene Expression Relation With Low-ovarian Reserve in Endometriomas
An observational study of Ovarian Reserve, Endometrioma, PTEN-AKT-FOXO3 Gene Expression, run by Uludag University at 2 sites in Turkey (Türkiye).
Trial summary
In this study, we aimed to investigate the relationship between PTEN-AKT-FOXO3 gene expression and decrease in ovarian reserve in the presence of endometrioma and other benign ovarian pathologies. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Reserve, Endometrioma, PTEN-AKT-FOXO3 Gene Expression
- What is being tested?
- PTEN-AKT-FOXO3 Gene Expression
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 27 May 2019to 30 Jun 2020
- Phase
- Observational
- 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 18 to 40 years
- Women only
- Adult
Study population: The study population is the patients examined for ovarian endometriomas and other benign ovarian pathologies
Who may be able to join
- 1) To be in the range of 18-40 years 2) Patients with an operation indication with >=5 cm endometrioma 3) Patients with operation plan due to non-endometrioma ovarian pathologies
Who cannot join
- 1)Patients over the age of 40 2)Patients with suspected malignancy 3)Follow-up patients without indications for operation
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Uludag University Hospital, Department of Obstetrics and Gynecology
Bursa, Nilufer, 16059
HAMZA F SEN, MD, +90 5443939159, hamzafurkansen@yahoo.com
Isil Kasapoglu, MD, +905305455848, kasapogluisil@hotmail.com
- Recruiting
Uludag University Hospital, Department of Obstetrics and Gynecology
Bursa, Nilufer, 16059
H.FURKAN MD SEN, +90 5443939159, hamzafurkansen@yahoo.com
Isil MD Kasapoglu, +905305455848, kasapogluisil@hotmail.com
About this study
Official title: RELATIONSHIP OF LOW-OVER RESERVE WITH PTEN-AKT-FOXO3 GENE EXPRESSION IN THE PRESENCE OF ENDOMETRIOMAS
In this study, we aimed to investigate the relationship between PTEN-AKT-FOXO3 gene expression and decrease in ovarian reserve in the presence of endometrioma and other benign ovarian pathologies.
Read the detailed description
It is known that the presence of endometrioma negatively affects ovarian reserve. The development of endometriosis and the effect of the presence of endometrioma on ovarian reserve due to decreased PTEN expression are considered. This study was designed to compare ovarian PTEN-AKT-FOXO3 gene expression and ovarian reserve in patients with underwent surgery caused by endometrioma and those who had ovarian pathology due to other benign causes and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.
- Being tested
- PTEN-AKT-FOXO3 Gene Expression
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTEN-AKT-FOXO3 Gene ExpressionGenetic
In the patient and patient control groups, 0.5 mm tissue strip will be removed for pathology from the cyst wall removed during surgery. and tissue samples will be stored in phosphate buffered saline at -80 C and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.
| Study group | Role | What they receive |
|---|---|---|
| PATİENCE GROUP | 1. To be in the range of 18-40 years
2. Patients with an operation indication with >=5 cm endometrioma
1. Symptomatic patients due to endometrioma (dysmenorrhea, dyspareunia, chronic pelvic pain, etc.)
2. Patients who will be followed for IVF cycle due to infertility Receives: Genetic: PTEN-AKT-FOXO3 Gene Expression | |
| PATİENCE-CONTROL GROUP | 1. To be in the range of 18-40 years
2. Patients with operation plan due to non-endometrioma ovarian pathologies
1. Symptomatic patients with benign ovarian pathology (such as chronic pelvic pain, compression, syphilomas, dysmenorrhea, dyspareunia, etc.)
2. Asymptomatic, despite a 6-month follow-up period, increase in cyst size or become symptomatic Receives: Genetic: PTEN-AKT-FOXO3 Gene Expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTEN AKT FOXO3 gene expression
In the patient and patient control groups, 0.5 mm tissue strip will be removed for pathology from the cyst wall removed during surgery. and tissue samples will be stored in phosphate buffered saline at -80 C and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start27 May 2019
- Primary completion27 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian Reserve, Endometrioma, PTEN-AKT-FOXO3 Gene ExpressionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜRKAN UNCU,PROF. MD, Uludag University
- Investigators
- GURKAN UNCU, Prof, Study director, ULUDAG UNIVERSITY HOSPITAL BURSA TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058912
- Sponsor's protocol ID
- UU-MREC-2019-5/28
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Govatati S, Kodati VL, Deenadayal M, Chakravarty B, Shivaji S, Bhanoori M. Mutations in the PTEN tumor gene and risk of endometriosis: a case-control study. Hum Reprod. 2014 Feb;29(2):324-36. doi: 10.1093/humrep/det387. Epub 2013 Oct 23.
PubMed 24154570Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.
PubMed 29935810
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELATIONSHIP OF LOW-OVER RESERVE WITH PTEN-AKT-FOXO3 GENE EXPRESSION IN THE PRESENCE OF ENDOMETRIOMAS
- ClinicalTrials.gov ID
- NCT04058912
- Acronym / sponsor ID
- UU-MREC-2019-5/28
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- 27 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 16 Aug 2019 (actual)
- 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.
In this study, we aimed to investigate the relationship between PTEN-AKT-FOXO3 gene expression and decrease in ovarian reserve in the presence of endometrioma and other benign ovarian pathologies.
Detailed description
It is known that the presence of endometrioma negatively affects ovarian reserve. The development of endometriosis and the effect of the presence of endometrioma on ovarian reserve due to decreased PTEN expression are considered. This study was designed to compare ovarian PTEN-AKT-FOXO3 gene expression and ovarian reserve in patients with underwent surgery caused by endometrioma and those who had ovarian pathology due to other benign causes and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATİENCE GROUP | – | Genetic: PTEN-AKT-FOXO3 Gene Expression1. To be in the range of 18-40 years 2. Patients with an operation indication with >=5 cm endometrioma 1. Symptomatic patients due to endometrioma (dysmenorrhea, dyspareunia, chronic pelvic pain, etc.) 2. Patients who will be followed for IVF cycle due to infertility |
| PATİENCE-CONTROL GROUP | – | Genetic: PTEN-AKT-FOXO3 Gene Expression1. To be in the range of 18-40 years 2. Patients with operation plan due to non-endometrioma ovarian pathologies 1. Symptomatic patients with benign ovarian pathology (such as chronic pelvic pain, compression, syphilomas, dysmenorrhea, dyspareunia, etc.) 2. Asymptomatic, despite a 6-month follow-up period, increase in cyst size or become symptomatic |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study population is the patients examined for ovarian endometriomas and other benign ovarian pathologies
Key inclusion criteria (1 listed)
- 1) To be in the range of 18-40 years 2) Patients with an operation indication with >=5 cm endometrioma 3) Patients with operation plan due to non-endometrioma ovarian pathologies
Key exclusion criteria (1 listed)
- 1)Patients over the age of 40 2)Patients with suspected malignancy 3)Follow-up patients without indications for operation
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 |
|---|---|---|
| PTEN-AKT-FOXO3 Gene ExpressionIn the patient and patient control groups, 0.5 mm tissue strip will be removed for pathology from the cyst wall removed during surgery. and tissue samples will be stored in phosphate buffered saline at -80 C and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis. | Genetic | PATİENCE GROUP, PATİENCE-CONTROL GROUP |
Primary outcome
PTEN AKT FOXO3 gene expression
Time frame: 30 minutes
In the patient and patient control groups, 0.5 mm tissue strip will be removed for pathology from the cyst wall removed during surgery. and tissue samples will be stored in phosphate buffered saline at -80 C and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Background: PubMed 24154570Govatati S, Kodati VL, Deenadayal M, Chakravarty B, Shivaji S, Bhanoori M. Mutations in the PTEN tumor gene and risk of endometriosis: a case-control study. Hum Reprod. 2014 Feb;29(2):324-36. doi: 10.1093/humrep/det387. Epub 2013 Oct 23.
- Background: PubMed 29935810Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.
- Individual participant dataSharing planned: No
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.
GURKAN UNCU, Prof study director
ULUDAG UNIVERSITY HOSPITAL BURSA TURKEY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Reserve, Endometrioma, PTEN-AKT-FOXO3 Gene Expression, run by Uludag University at 2 sites 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: status not confirmed, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HAMZA F SEN, MD (+90 544 3939159, hamzafurkansen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTEN AKT FOXO3 gene expression (time frame: 30 minutes). 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 NCT04058912, which also lists 2 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 16 Aug 2019.