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NCT Number: NCT07048327

Cohort Study of Intrauterine Diseases

"This study employs a prospective cohort design by establishing a uterine cavity diseases research platform. The investigators will collect participants' current medical history, menstrual and obstetric history, past medical history, physical and gynecological examinations, imaging studies, laboratory tests, and pathological examinations. After the hysteroscopic surgery, the investigators will conduct a one-year follow-up on the disease progression of the participants. Through this comprehensive approach, the investigators aim to deeply investigate the pathogenesis, risk factors, and optimized treatment strategies for uterine cavity diseases."

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location status: Recruiting

Location contact

Pu Zhou

CONTACT

[email protected]

+86-027-83662379

Wen W Wang, Dr.

PRINCIPAL_INVESTIGATOR

About this study

Uterine cavity diseases are a common category of hormone-dependent gynecological conditions, encompassing a wide spectrum from benign lesions to malignant tumors, including endometrial hyperplasia, endometrial polyps, and endometrial malignancies.

Endometrial hyperplasia is classified into two types: hyperplasia without atypia and atypical hyperplasia. Atypical hyperplasia is considered a precancerous lesion of endometrial malignancies, which may lead to irregular vaginal bleeding, menstrual disorders, and carries the risk of malignant transformation. Endometrial polyps, a common benign lesion within the uterine cavity, often cause abnormal uterine bleeding, infertility, or recurrent miscarriages, significantly impacting women's reproductive health and quality of life. Endometrial malignancies, the most prevalent malignant tumors in the female reproductive system, pose a serious threat to women's lives and safety. These diseases not only profoundly affect women's physical health but also have far-reaching negative consequences on their mental well-being, social functioning, and overall quality of life.

In light of this, this study aims to utilize patients' clinical data resources to establish a cohort research platform for uterine cavity diseases, bridging the gap between clinical practice and scientific research, and providing valuable clinical data resources for in-depth studies on these conditions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-80 years;
  • Patients requiring hysteroscopy or diagnostic curettage for intrauterine pathologies (e.g., endometrial hyperplasia, endometrial polyps, submucosal uterine fibroids, adenomyosis, or endometrial malignancies);
  • Willing and able to comply with follow-up requirements;
  • Signed informed consent obtained.

Exclusion criteria

  • Concurrent participation in other drug clinical trials;
  • Contraindications to or inability to tolerate hysteroscopy/curettage procedures;
  • Unwilling or unable to provide informed consent;
  • Unwilling or unable to adhere to study protocols.

Treatment and study plan

No intervention (observational study)

Other

No intervention (observational study)

Primary outcomes

  1. The recurrence of endometrial polyps or endometrial hyperplasia.

    Time frame: Follow up every three months for one year after hysteroscopic surgery

    To evaluate the presence of disease progression and recurrence through imaging results.

Study contacts

Contact information is provided by the study sponsor or research team.

Wen W Wang, Dr.

CONTACT

[email protected]

+86 15927167698

Sponsors and collaborators

Lead sponsor

Wenwen Wang

Other

Registry information

Acronym: TJ Intrauterin

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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