NCT03682341

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

September 20, 2018

Last Update Submit

September 20, 2018

Conditions

Recruitment

Outcome Measures

Primary Outcomes (1)

  • difference in ovarian reserve function

    different ovarian reserve function in patients with or without ovarian endometriosis

    4 months

Secondary Outcomes (1)

  • FOXO3A-bim pathway gene polymorphism

    4 months

Study Arms (2)

Group A

Patients with ovarian endometriosis cyst

Genetic: endometriosis

Group B

Patients with ovarian teratoma cyst

Genetic: endometriosis

Interventions

endometriosisGENETIC

patients with or without ovarian endometriosis

Group AGroup B

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with ovarian endometriosis cyst and teratoma cyst

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 37572646DERIVED

Study Officials

  • Jinhua Leng, professor

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Xiaoyan Li

CONTACT

860169155649magiclynn@vip.sina.com

Xiaoyan Li

CONTACT

86-18610219518lixiaoyan@pumch.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 24, 2018

Study Start

September 20, 2018

Primary Completion

December 1, 2018

Study Completion

December 30, 2018

Last Updated

September 24, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share