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To explore the molecular mechanism of recurrent spontaneous abortion caused by abnormal decidualization

The Mechanism of low ACLY expression disrupting acetyl-CoA-H3K27ac axis causing abnormal decidualization and recurrent spontaneous abortion

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119314
Enrollment
Unknown
Registered
2026-02-25
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

recurrent spontaneous abortion

Interventions

RSA group:None
Control group of induced abortion with previous pregnancy history:None
Women of childbearing age with different menstrual cycles:None

Sponsors

Hangzhou Women's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for the group of women of childbearing age with different menstrual cycles: (1) Female, aged 20 to 40 years old (inclusive). (2) The ovulation cycle is 21 to 35 days (inclusive of 21 and 35 days). (3) Patients with non-recurrent miscarriage factors who underwent hysteroscopy or uterine surgery. (4) There was no history of hormone therapy or fallopian tube or ovarian surgery in the three months prior to sampling. 2. Inclusion criteria for the RSA group: (1) Female, aged 20 to 40 years (inclusive). (2) The ovulation cycle is 21 to 35 days (inclusive of 21 and 35 days). (3) Patients with early pregnancy (gestational weeks =2 consecutive pregnancy failures. (4) Normal ovarian reserve and endocrine levels (FSH < 10 mIU/mL, LH < 10 mIU/mL, E2 < 50 pg/mL). 3. Inclusion criteria for the control group of induced abortion with a previous pregnancy history (1) Female, aged 20 to 40 (inclusive). (2) The ovulation cycle is 21 to 35 days (inclusive of 21 and 35 days). (3) Healthy women with normal early intrauterine pregnancies who voluntarily request to terminate the pregnancy and undergo artificial abortion due to non-medical reasons (such as personal plans, social factors, etc.), and have at least one history of full-term delivery or normal pregnancy, without any history of spontaneous abortion, stillbirth, stillbirth or other adverse pregnancy and childbirth. (4) Normal ovarian reserve and endocrine levels (FSH < 10 mIU/mL, LH < 10 mIU/mL, E2 < 50 pg/mL).

Exclusion criteria

Exclusion criteria: 1. Anatomical structural abnormalities: The presence of uterine malformations (such as septate uterus, bicornuate uterus), Asherman syndrome (intrauterine adhesions), uterine fibroids (with a diameter of 4cm or submucosal fibroids), and other anatomical factors that may affect embryo implantation is confirmed by examinations such as ultrasound, hysteroscopy or angiography. 2. Chromosomal abnormalities: Either spouse has a clear abnormality identified by karyotype analysis. 3. Endocrine diseases: Suffering from poorly controlled or untreated severe endocrine diseases, such as: Abnormal thyroid function (hyperthyroidism or hypothyroidism, with TSH significantly exceeding the normal range) Uncontrolled diabetes (fasting blood glucose >=7.0 mmol/L) Immune system diseases: Suffering from definite autoimmune diseases, such as antiphospholipid syndrome (APS), systemic lupus erythematosus (SLE), undifferentiated connective tissue disease, etc., or persistently positive related autoantibodies (such as anticardiolipin antibodies, anti-ß 2-GP1 antibodies, lupus anticoagulants). 4. Infection factors: This miscarriage was caused by reproductive tract infections (such as chlamydia, mycoplasma, TORCH, etc.). 5. Pre-thrombotic state: There are known thrombophilia related to miscarriage (such as protein S/C deficiency, antithrombin III deficiency, etc.). 6. Other major diseases: Those with severe primary diseases of the heart, liver, kidneys, blood system, etc., or those who cannot cooperate with mental disorders. 7. Drug impact: There is a recent history (such as within 3 months) of taking drugs that may affect metabolism or immune function (such as glucocorticoids, metformin, insulin, weight loss drugs, etc.). 8. Extreme lifestyle: Has long-term bad habits such as heavy drinking, smoking and drug abuse. 9. Unqualified tissue samples: The amount of endometrial tissue or decidua tissue obtained during the surgery is too small or cannot be used for subsequent research due to improper handling. 10. Postoperative pathology suggests a malignant tumor.

Design outcomes

Primary

MeasureTime frame
Basic information: age, height, weight, BMI, menstrual cycle, reproductive history, number of miscarriages and their causes, etc.;Laboratory tests: Ovarian function (AMH), thyroid function (TSH, T3, T4, etc.), autoimmune antibodies (anticardiolipin antibodies IgG, IgA, IgM, anti-ß 2-glycoprotein 1 antibodies, etc.), etc;

Countries

China

Contacts

Public ContactMengying Liu

Hangzhou Women's Hospital

liumy1224@163.com+86 571 5600 5077

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026