Interleukin-10 Promoter-1082A/G Polymorphism and Idiopathic Recurrent Miscarriage Risk
Association Between Interleukin-10 Promoter-1082A/G Polymorphism With Idiopathic Recurrent Miscarriage Risk of Chinese Han
1 other identifier
observational
200
1 country
2
Brief Summary
This study aimed to assess the correlation between the interleukin-10 (IL-10)-1082A/G polymorphism and idiopathic recurrent miscarriage (IRM) of Chinese Han. A total of 100 women with IRM and 100 control women with a successful pregnancy will be included in this study. Then genotyping will be performed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2015
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 11, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 15, 2017
February 1, 2017
2.3 years
December 11, 2015
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
genetic polymorphisms associated with idiopathic recurrent miscarriage
Identification of genetic polymorphisms that are associated with idiopathic recurrent miscarriage
within one year (plus or minus 1 month) after surgery
Secondary Outcomes (1)
Indexes in the routine blood test and blood coagulation test
During pregnancy and three months after miscarriage
Study Arms (2)
CONTROL: women no miscarriage
Group of patients who referred to the Fourth Affiliated Hospital of Guangxi Medical University or Liuzhou Maternity and Child Healthcare Hospital, who have more than one successful pregnancy without miscarriage. Then the blood sample will be collected and the IL-10 Polymorphism will be analyzed.
CASE: patients with IRM
Group of patients who referred to the Fourth Affiliated Hospital of Guangxi Medical University or Liuzhou Maternity and Child Healthcare Hospital, who have more than three consecutive miscarriages without clear cause (Idiopathic Recurrent Miscarriage, IRM). Then the blood sample will be collected and the IL-10 Polymorphism will be analyzed.
Interventions
The IL-10 genotype will determined by polymerase chain reaction (PCR) amplication and restriction length fragment polymorphisms.
Eligibility Criteria
Female patients who referred to the Fourth Affiliated Hospital of Guangxi Medical University or Liuzhou Maternity and Child Healthcare Hospital
You may qualify if:
- women with more than three consecutive unexplained pregnancy losses before the 20th week;
- Chinese Han Population;
- Patients who signed informed consent.
You may not qualify if:
- Patients who had other high-risk factors which might relate with recurrent miscarriage, including: (1) Parental karyotype abnormalities: significant rearrangements (e.g. balanced translocations and mosaics) were considered abnormal. If either the patient (or her partner) had an abnormal karyotype, it was considered a parental karyotypic abnormality; (2) Genital tract abnormalities: Any congenital anatomical deformation of the genital tract was considered abnormal; intrauterine adhesions, endometriosis and hydrosalpinx were also considered abnormal; (3) alloimmune disorder; (4) Endocrine abnormalities: prolactin (PRL) level \>25 ng/ml, testosterone level \>2.6 nmol/L, thyroid-stimulating hormone level \<0.30 mU/L or \>4.5 mU/L, free thyroxine (FT4) level \<8.36 nmol/L or \>29.6 nmol/L and free triiodothyronine (FT3) level \<1.84 nmol/L or \>7.39 nmol/L. Glucose level \> 126mg/dl; (5) Autoimmune disorders: Any positive results of Anti-cardiolipin antibodies (ACA-IgG/IgM/IgA), anti-nuclear antibodies (ANA-IgG), anti-endometrium antibodies (AEA-IgM), anti-ovary antibodies (AOA-IgM), anti-sperm antibodies (ASA-IgM), antithyroidin(TG-Ab), anti-thyroid peroxidase antibody(TPO-Ab) and/or anti-chorionic gonadotropin hormone antibody; (6) Hypercoagulation state: D-dimer levels \>260 ng/ml, fibrin degradation products (FDP) levels \>5 mg/L or anti-beta 2-glycoprotein I (anti-beta 2-GP1) levels \>15 U/ml; (7) Negative RH blood groups; (8) Abnormal semen routine results of patients husband.
- Patients with serious diseases;
- Patients with administration of contraceptive pills;
- Patients participated in other randomized clinical research;
- Patients could not be followed-up of a long time or had poor compliance;
- Patients with other factors that would affect the study result.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Liuzhou Maternal and Child Health Care Hospital
Liuchow, Guangxi, 545000, China
the Fourth Affiliated Hospital of Guangxi Medical University
Liuchow, Guangxi, 545000, China
Biospecimen
blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangcheng Wei
Guangxi Medical University Institutional Review Board
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2015
First Posted
December 17, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
February 15, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share