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Oxidative Stress Gene Polymorphism and Ovarian Reserve Functione

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ClinicalTrials.gov Identifier: NCT03682341
Recruitment Status : Unknown
Verified September 2018 by Peking Union Medical College Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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Brief Summary:
the relationship between FOXO3A-bim pathway gene polymorphisms and ovarian reserve function of paitients with ovarian endometrioma

Condition or disease Intervention/treatment
Recruitment Genetic: endometriosis

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Study of the Relationship Between Oxidative Stress Gene Polymorphism and Individual Variation of Ovarian Reserve Function in Patients With Ovarian Endometrioma
Estimated Study Start Date : September 20, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 30, 2018

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Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. difference in ovarian reserve function [ Time Frame: 4 months ]
    different ovarian reserve function in patients with or without ovarian endometriosis


Secondary Outcome Measures :
  1. FOXO3A-bim pathway gene polymorphism [ Time Frame: 4 months ]
    FOXO3A-bim pathway gene polymorphism in patients with or without ovarian endometriosis


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with ovarian endometriosis cyst and teratoma cyst
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682341


Contacts
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Contact: Xiaoyan Li 860169155649 magiclynn@vip.sina.com
Contact: Xiaoyan Li 86-18610219518 lixiaoyan@pumch.cn

Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Director: Jinhua Leng, professor Peking Union Medical College Hospital
More Information
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Additional Information:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03682341    
Other Study ID Numbers: endometriosis oxidative stress
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No