Oxidative Stress Gene Polymorphism and Ovarian Reserve Functione

September 20, 2018 updated by: Peking Union Medical College Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with ovarian endometriosis cyst and teratoma cyst

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Patients with ovarian endometriosis cyst
Genetic: endometriosis
patients with or without ovarian endometriosis
Group B
Patients with ovarian teratoma cyst
Genetic: endometriosis
patients with or without ovarian endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in ovarian reserve function
Time Frame: 4 months
different ovarian reserve function in patients with or without ovarian endometriosis
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FOXO3A-bim pathway gene polymorphism
Time Frame: 4 months
FOXO3A-bim pathway gene polymorphism in patients with or without ovarian endometriosis
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Director: Jinhua Leng, professor, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 20, 2018

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 30, 2018

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 20, 2018

First Posted (ACTUAL)

September 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • endometriosis oxidative stress

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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