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

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.

Study Overview

• Status: Unknown
• Conditions: Abortion, Spontaneous
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Zheng Peng; Phone Number: +86 18589966550; Email: labstar@qq.com
• Study Contact Backup: Name: Xiaolan Lv; Phone Number: +86 15577727711; Email: labsun@qq.com

Study Locations

• China
  • Guangxi
    • Liuzhou, Guangxi, China, 545000
      • Recruiting
      • Liuzhou Maternal and Child Health Care Hospital
      • Contact: Xiaolan Lv
    • Liuzhou, Guangxi, China, 545000
      • Recruiting
      • The Fourth Affiliated Hospital of Guangxi Medical University
      • Contact: Zheng Peng; Email: 133303@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indexes in the routine blood test and blood coagulation test	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.	During pregnancy and three months after miscarriage

Collaborators and Investigators

• Sponsor: Fourth Affiliated Hospital of Guangxi Medical University
• Collaborators: Liuzhou Maternity and Child Healthcare Hospital
• Investigators: Principal Investigator: Xiangcheng Wei, Guangxi Medical University Institutional Review Board

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Polymorphism, Single Nucleotide; interleukin-10
• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Habitual
• Other Study ID Numbers: PJK201583

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No