Comparing Medroxyprogesterone Acetate and LNG-IUS for Fertility Preservation in Early-stage Endometrial Cancer
The Therapeutic Effect of Medroxyprogesterone Acetate vs. LNG-IUS in Early-stage Endometrioid Carcinoma
This study is testing whether a medication called Medroxyprogesterone Acetate or an intrauterine device can better help young women with early-stage endometrial cancer keep their fertility while treating their cancer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | Female |
| Sponsor | Beijing Chao Yang Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05565573 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Medroxyprogesterone Acetate (MPA) compared to the Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in treating young patients with early-stage endometrioid carcinoma and atypical hyperplasia while preserving their fertility. The study focuses on patients aged 45 and younger who have been diagnosed with highly differentiated endometrioid adenocarcinoma and meet specific inclusion criteria. By comparing these two fertility-sparing treatment options, the trial seeks to provide evidence-based guidelines for managing young women with early gynecological tumors. The outcomes will help determine the best approach for both tumor control and pregnancy success.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 45 and younger with early-stage endometrioid carcinoma who wish to preserve their fertility.
Not a fit: Patients with type II endometrial cancer or those with contraindications to progesterone therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective fertility-preserving treatment option for young women diagnosed with early-stage endometrial cancer.
How similar studies have performed: Previous studies have shown promising results for fertility-sparing treatments in early-stage endometrial cancer, suggesting that this approach is both feasible and safe.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≤ 45 years old; 2. Diagnostic curettage pathology is highly differentiated endometrioid adenocarcinoma; 3. pelvic augmentation MRI or / and vaginal color ultrasound Doppler examination, tumor confined endometrium; 4. No suspicious metastatic lesions; 5. Endometrial pathological tissue specimens with strong positive expression of estrogen and progesterone receptors; 6. Blood CA125 is normal; 7. no progesterone therapy and contraindications to pregnancy; 8. The patient himself has a strong desire to preserve fertility, and the patient should fully understand that fertility preservation treatment is not the standard treatment method; 9. Conditional acceptance of close follow-up. Exclusion Criteria: 1. type II endometrial cancer; 2. Patients with abnormal liver and kidney function and other contraindications to progesterone therapy; 3. Other parts of the body are concurrent or successively complicated by other malignant tumors; 4. The patient and his/her family are unable to sign the informed consent form for any reason; 5. Unconditional follow-up.
Where this trial is running
Beijing, Beijing
- Bei Jing Chao-Yang Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Hengzi Sun, Ph.D
- Email: summerel1990@163.com
- Phone: +86 18811151901
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.