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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03682341
Other study ID # endometriosis oxidative stress
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 20, 2018
Est. completion date December 30, 2018

Study information

Verified date September 2018
Source Peking Union Medical College Hospital
Contact Xiaoyan Li
Phone 860169155649
Email magiclynn@vip.sina.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

the relationship between FOXO3A-bim pathway gene polymorphisms and ovarian reserve function of paitients with ovarian endometrioma


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 30, 2018
Est. primary completion date December 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Genetic:
endometriosis
patients with or without ovarian endometriosis

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary difference in ovarian reserve function different ovarian reserve function in patients with or without ovarian endometriosis 4 months
Secondary FOXO3A-bim pathway gene polymorphism FOXO3A-bim pathway gene polymorphism in patients with or without ovarian endometriosis 4 months
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