RecruitmentNCT03682341
Oxidative Stress Gene Polymorphism and Ovarian Reserve Functione
An observational study of Recruitment, run by Peking Union Medical College Hospital.
Trial summary
the relationship between FOXO3A-bim pathway gene polymorphisms and ovarian reserve function of paitients with ovarian endometrioma Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recruitment
- What is being tested?
- endometriosis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2018to 30 Dec 2018
- How long will I take part?
- 4 Months
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with ovarian endometriosis cyst and teratoma cyst
Who may be able to join
- 20 to 35 years old, non-menstrual period, not in pregnancy or puerperal period, diagnosed with ovarian cyst according to preoperative clinical symptoms, physical examination, ultrasound, CA125 and other non-surgical diagnosis methods, and all the participants having surgical indications, and ultimately conformed through histopathological diagnosis
Who cannot join
- Participants receiving hormone therapy within the past six months, HIV or hepatitis B/C positive, autoimmune diseases, endocrine diseases and systemic diseases (such as diabetes, hormone therapy diseases, severe liver and kidney dysfunction), severe mental illness and malignant tumors.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of the Relationship Between Oxidative Stress Gene Polymorphism and Individual Variation of Ovarian Reserve Function in Patients With Ovarian Endometrioma
the relationship between FOXO3A-bim pathway gene polymorphisms and ovarian reserve function of paitients with ovarian endometrioma
Read the detailed description
Ovarian reserve refers to the left ovarian cortex follicle growth, development, the quantity and quality of potential ability of oocytes, reflects the fertility in women. Ovarian endometrioms have an effect on ovarian reserve function. Oxidative stress is one of the important reasons. The effect has individual differences and the mechanisms are not clear.FOXO3A-bim pathway gene polymorphisms have been reported to related to individual variation of ovarian reserve function of paitients with POF. Our working hypothesis is that FOXO3A-bim pathway gene polymorphisms are also related to ovarian reserve function of paitients with ovarian endometrioma. In recent 10 years, we have set up a database including more than 2000 cases of ovarian endometrioma. In this project, we are going to investigate the oxidative stress factors, the level of sexual hormone, ultrasound information and the relationship between FOXO3A-bim pathway gene polymorphism.All these multi-diciplinary research will lead to novel understanding of individual variation of ovarian reserve function.
- Conditions
- Recruitment
- Being tested
- endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometriosisGenetic
patients with or without ovarian endometriosis
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with ovarian endometriosis cyst Receives: Genetic: endometriosis | |
| Group B | Patients with ovarian teratoma cyst Receives: Genetic: endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in ovarian reserve function
different ovarian reserve function in patients with or without ovarian endometriosis
Measured: 4 months
Secondary outcomes (1)
FOXO3A-bim pathway gene polymorphism
FOXO3A-bim pathway gene polymorphism in patients with or without ovarian endometriosis
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start20 Sep 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RecruitmentStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinhua Leng, professor, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682341
- Sponsor's protocol ID
- endometriosis oxidative stress
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li XY, Wang X, Gu ZY, Sun TT, Leng JH, Yu Q. Combined proteomics and transcriptomics identifies serpin family C member 1 associated protein as a biomarker of endometriosis. Ann Med. 2023;55(2):2243825. doi: 10.1080/07853890.2023.2243825.
PubMed 37572646
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship Between Oxidative Stress Gene Polymorphism and Individual Variation of Ovarian Reserve Function in Patients With Ovarian Endometrioma
- ClinicalTrials.gov ID
- NCT03682341
- Acronym / sponsor ID
- endometriosis oxidative stress
- Conditions
- Recruitment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Sep 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 24 Sep 2018 (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.
the relationship between FOXO3A-bim pathway gene polymorphisms and ovarian reserve function of paitients with ovarian endometrioma
Detailed description
Ovarian reserve refers to the left ovarian cortex follicle growth, development, the quantity and quality of potential ability of oocytes, reflects the fertility in women. Ovarian endometrioms have an effect on ovarian reserve function. Oxidative stress is one of the important reasons. The effect has individual differences and the mechanisms are not clear.FOXO3A-bim pathway gene polymorphisms have been reported to related to individual variation of ovarian reserve function of paitients with POF. Our working hypothesis is that FOXO3A-bim pathway gene polymorphisms are also related to ovarian reserve function of paitients with ovarian endometrioma. In recent 10 years, we have set up a database including more than 2000 cases of ovarian endometrioma. In this project, we are going to investigate the oxidative stress factors, the level of sexual hormone, ultrasound information and the relationship between FOXO3A-bim pathway gene polymorphism.All these multi-diciplinary research will lead to novel understanding of individual variation of ovarian reserve function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Genetic: endometriosisPatients with ovarian endometriosis cyst |
| Group B | – | Genetic: endometriosisPatients with ovarian teratoma cyst |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with ovarian endometriosis cyst and teratoma cyst
Key inclusion criteria (1 listed)
- 20 to 35 years old, non-menstrual period, not in pregnancy or puerperal period, diagnosed with ovarian cyst according to preoperative clinical symptoms, physical examination, ultrasound, CA125 and other non-surgical diagnosis methods, and all the participants having surgical indications, and ultimately conformed through histopathological diagnosis
Key exclusion criteria (1 listed)
- Participants receiving hormone therapy within the past six months, HIV or hepatitis B/C positive, autoimmune diseases, endocrine diseases and systemic diseases (such as diabetes, hormone therapy diseases, severe liver and kidney dysfunction), severe mental illness and malignant tumors.
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 |
|---|---|---|
| endometriosispatients with or without ovarian endometriosis | Genetic | Group A, Group B |
Primary outcome
difference in ovarian reserve function
Time frame: 4 months
different ovarian reserve function in patients with or without ovarian endometriosis
1 secondary outcome
FOXO3A-bim pathway gene polymorphism
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Derived from this study: PubMed 37572646Li XY, Wang X, Gu ZY, Sun TT, Leng JH, Yu Q. Combined proteomics and transcriptomics identifies serpin family C member 1 associated protein as a biomarker of endometriosis. Ann Med. 2023;55(2):2243825. doi: 10.1080/07853890.2023.2243825.
- Individual participant dataSharing planned: No
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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.
Jinhua Leng, professor study director
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Recruitment, run by Peking Union Medical College Hospital.
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 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaoyan Li (860169155649, magiclynn@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in ovarian reserve function (time frame: 4 months). 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 NCT03682341, which also lists 1 linked publication.
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 24 Sep 2018.