Evaluating a fertility-preserving treatment for early-stage endometrial cancer and hyperplasia
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
NA · Women's Hospital School Of Medicine Zhejiang University · NCT06417736
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06417736 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometrial Cancer Stage I, Endometrial Hyperplasia