Evaluating a fertility-preserving treatment for early-stage endometrial cancer and hyperplasia
Official title: Prospective Clinical Study of Fertility-sparing Treatment With a Membrane-inhibiting Formula Combined With Oral Progestins for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women
Run by Women's Hospital School Of Medicine Zhejiang University · NCT06417736 · Data updated 2026-11-12
This study is testing a new treatment for early-stage endometrial cancer and hyperplasia to see if it can help women of childbearing age preserve their fertility while managing their condition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 75 (estimated) |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | July 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | May 16, 2024 |
| Trial ID | NCT06417736 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18-45 with a strong desire to preserve fertility and diagnosed with grade 1 or grade 2 endometrioid endometrial carcinoma or hyperplasia.
✕Probably not a fit
Patients with contraindications for pregnancy, those not requiring fertility preservation, or those with advanced cancer stages will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the effectiveness and side effects of a membrane-inhibiting formula combined with oral progestins as a treatment option for women of childbearing age diagnosed with early-stage endometrial cancer and hyperplasia. Participants will take the treatment daily and attend clinic visits every three months for checkups, tests, and hysteroscopy. The study will investigate the time to complete endometrial remission, potential medical issues arising from the treatment, and outcomes related to pregnancy and recurrence across different molecular classifications of the disease.
Why it matters
Potential benefit: If successful, this treatment could provide a viable option for women wishing to preserve their fertility while managing early-stage endometrial cancer and hyperplasia.
How similar studies have gone: While there is ongoing research in fertility-preserving treatments for endometrial conditions, this specific approach combining a membrane-inhibiting formula with oral progestins is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.18-45 years old with a strong desire to preserve fertility; 2. pathologically diagnosed with primary grade1 or grade2 endometrioid endometrial carcinoma and hyperplasia 3.no signs of suspicious myometrial invasion by enhanced magnetic resonance imaging (MRI) 4. no signs of suspicious extrauterine metastasis by enhanced computed tomography and CT scan of the Lungs Exclusion Criteria: * 1.have contraindication for pregnancy. 2.no fertility requiremen 3.have myometrial invasion or extrauterine metastasis 4.pathologically diagnosed with primary grade3 endometrioid endometrial carcinoma or non-endometrioid endometrial carcinoma 5.Any disease or symptom that may affect the implementation of the study or the interpretation of the results
Where it's running
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Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Yang Li, Doctor — Women's Hospital School Of Medicine Zhejiang University
- Study coordinator: Yang Li, Doctor
- Email: 5516015@zju.edu.cn
- Phone: 0086-18268165386
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Progestins before surgery for endometrial cancer or precancers
This phase II study tests two progestin options (megestrol acetate vs. micronized progesterone) for women with endometrial cancer or atypical endometrial hyperplasia before they have surgery.
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Fertility-preserving hysteroscopic treatment outcomes for endometrial cancer and atypical hyperplasia
This project tests whether removing lesions by hysteroscopy combined with hormonal therapy helps women with endometrial cancer or atypical hyperplasia preserve fertility and achieve good pregnancy and cancer-control outcomes.
-
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This project will follow adults with endometrial polyps, hyperplasia, or cancer who undergo hysteroscopy to see if detailed clinical and pathology data can predict disease course over one year.
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This test checks whether using four cervical methylene blue injections instead of the usual two helps surgeons find sentinel lymph nodes in people with newly diagnosed stage I endometrial cancer who are having surgery.
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This study is testing if using ultrasound to guide endometrial biopsies can help women with post-menopausal bleeding get better tissue samples and avoid more invasive procedures.
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Evaluating dostarlimab as a non-surgical treatment for early-stage endometrial cancer
This study is testing if a new immunotherapy drug called dostarlimab can be a safe and effective non-surgical treatment for women with early-stage endometrial cancer who want to keep their fertility or can't have surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.