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Trial record 3 of 32 for:    Interleukin-10

Interleukin-10 Promoter-1082A/G Polymorphism and Idiopathic Recurrent Miscarriage Risk

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ClinicalTrials.gov Identifier: NCT02633475
Recruitment Status : Unknown
Verified February 2017 by Fourth Affiliated Hospital of Guangxi Medical University.
Recruitment status was:  Recruiting
First Posted : December 17, 2015
Last Update Posted : February 15, 2017
Sponsor:
Collaborator:
Liuzhou Maternity and Child Healthcare Hospital
Information provided by (Responsible Party):
Fourth Affiliated Hospital of Guangxi Medical University

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.

Condition or disease Intervention/treatment
Abortion, Spontaneous Genetic: IL-10 polymorphism

Detailed Description:

As a common occurrence in early pregnancy, IRM has been associated with multiple causes, among which the disorders of immune homeostasis between the fetus and the maternal immune system, maintained by cytokines from the complex regulatory network, are considered one of the potential etiological factors underlying IRM.

The IL-10 polymorphism -1082A/G (rs1800896), which is located in the promoter region of the IL-10 gene, was reported to be implicated in the abnormal expression of IL-10 in IRM by some studies.

However, no such reports about the association between IL-10 polymorphism -1082A/G and IRM risk in Chinese Han.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Association Between Interleukin-10 Promoter-1082A/G Polymorphism With Idiopathic Recurrent Miscarriage Risk of Chinese Han
Study Start Date : August 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Group/Cohort Intervention/treatment
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.
Genetic: IL-10 polymorphism
The IL-10 genotype will determined by polymerase chain reaction (PCR) amplication and restriction length fragment polymorphisms.

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.
Genetic: IL-10 polymorphism
The IL-10 genotype will determined by polymerase chain reaction (PCR) amplication and restriction length fragment polymorphisms.




Primary Outcome Measures :
  1. genetic polymorphisms associated with idiopathic recurrent miscarriage [ Time Frame: within one year (plus or minus 1 month) after surgery ]
    Identification of genetic polymorphisms that are associated with idiopathic recurrent miscarriage


Secondary Outcome Measures :
  1. Indexes in the routine blood test and blood coagulation test [ Time Frame: During pregnancy and three months after miscarriage ]
    To explore the differential indexes in the routine blood test and blood coagulation test between patients with idiopathic recurrent miscarriage and healthy women, such as: WBC, NEU, LYM, RBC, HB, RDW, MCV, PLT, MPV, PDW, PCT, Fib, D-dimer.


Biospecimen Retention:   Samples With DNA
blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female patients who referred to the Fourth Affiliated Hospital of Guangxi Medical University or Liuzhou Maternity and Child Healthcare Hospital
Criteria

Inclusion Criteria:

  1. women with more than three consecutive unexplained pregnancy losses before the 20th week;
  2. Chinese Han Population;
  3. Patients who signed informed consent.

Exclusion Criteria:

  1. 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.
  2. Patients with serious diseases;
  3. Patients with administration of contraceptive pills;
  4. Patients participated in other randomized clinical research;
  5. Patients could not be followed-up of a long time or had poor compliance;
  6. Patients with other factors that would affect the study result.

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): NCT02633475


Contacts
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Contact: Zheng Peng +86 18589966550 labstar@qq.com
Contact: Xiaolan Lv +86 15577727711 labsun@qq.com

Locations
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China, Guangxi
Liuzhou Maternal and Child Health Care Hospital Recruiting
Liuzhou, Guangxi, China, 545000
Contact: Xiaolan Lv         
the Fourth Affiliated Hospital of Guangxi Medical University Recruiting
Liuzhou, Guangxi, China, 545000
Contact: Zheng Peng       133303@gmail.com   
Sponsors and Collaborators
Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou Maternity and Child Healthcare Hospital
Investigators
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Principal Investigator: Xiangcheng Wei Guangxi Medical University Institutional Review Board

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Responsible Party: Fourth Affiliated Hospital of Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02633475     History of Changes
Other Study ID Numbers: PJK201583
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fourth Affiliated Hospital of Guangxi Medical University:
interleukin-10
Polymorphism, Single Nucleotide

Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications