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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02633475
Enrollment
200
Registered
2015-12-17
Start date
2015-08-31
Completion date
2017-12-31
Last updated
2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion, Spontaneous

Keywords

interleukin-10, Polymorphism, Single Nucleotide

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.

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.

Interventions

GENETICIL-10 polymorphism

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

Sponsors

Liuzhou Maternity and Child Healthcare Hospital
CollaboratorOTHER
Fourth Affiliated Hospital of Guangxi Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
genetic polymorphisms associated with idiopathic recurrent miscarriagewithin one year (plus or minus 1 month) after surgeryIdentification of genetic polymorphisms that are associated with idiopathic recurrent miscarriage

Secondary

MeasureTime frameDescription
Indexes in the routine blood test and blood coagulation testDuring pregnancy and three months after miscarriageTo 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.

Countries

China

Contacts

Primary ContactZheng Peng
labstar@qq.com+86 18589966550
Backup ContactXiaolan Lv
labsun@qq.com+86 15577727711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026