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A Prospective Observational Study on the Impact of Intrauterine Devices on Female Reproductive Tract Microecological Homeostasis: Dynamic Profiling of the Microbiota-Immune-Metabolic Network

A Prospective Observational Study on the Impact of Intrauterine Devices on Female Reproductive Tract Microecological Homeostasis: Dynamic Profiling of the Microbiota-Immune-Metabolic Network

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112759
Enrollment
Unknown
Registered
2025-11-19
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Infectious Diseases of the Female Genital Tract

Interventions

IUD placement:None
Non-IUD placement :none

Sponsors

Women's Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women aged 20-45 years, requesting IUD placerment

Exclusion criteria

Exclusion criteria: 1. Pregnancy, postpartum period, or lactation. 2. IUD insertion for emergency contraception; switching from oral contraceptives or contraceptive implants to an IUD; IUD replacement; or post-abortion IUD insertion. 3. Use of intravaginal preparations or douching within 7 days prior to enrollment. 4. Systemic use of antibiotics within 2 weeks prior to enrollment. 5. Diabetes or autoimmune diseases. 6. History of female reproductive system diseases (including reproductive tract infections, benign or malignant tumors, adenomyosis, polycystic ovary syndrome, endometriosis, uterine malformations, or vaginal septa). 7. History of major illnesses within the previous 30 days (e.g., acute myocardial infarction, cerebral infarction, malignant tumors). 8. History of chemotherapy, radiotherapy, or immunotherapy. 9. Smoking or alcohol abuse. 10. History of intrauterine procedures within the past 6 months. 11. History of hormone therapy within the past 6 months.

Design outcomes

Primary

MeasureTime frame
Alterations in the microbial composition of the vagina, cervix, and endometrium.;

Secondary

MeasureTime frame
Shifts in the local immune microenvironment of the reproductive tract after IUD placement;Effects of IUDs on the reproductive tract metabolic profile and the underlying mechanisms;

Countries

China

Contacts

Public ContactWeiguo Lv

Women's Hospital, School of Medicine, Zhejiang University

lbwg@zju.edu.cn+86 571 8999 5250

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026