Actively Recruiting
Intrauterine Injection of Type III Collage in FST of EC/AEH
Led by Wang Jianliu · Updated on 2026-03-30
30
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if intrauterine injection of "Recombinant Humanized Type III Collagen Lyophilized Fibers" works to treat endometrial cancer or atypical hyperplasia in patients seeking fertility-preserving treatment. It will also learn about the safety of this intervention.The main questions it aims to answer are: 1. Does the combination of recombinant humanized type III collagen and progestin significantly increase the tumor remission rate at 6 months compared to progestin alone? 2. What medical problems do participants have when receiving this treatment (e.g., allergic reactions, abnormal inflammatory markers, or histocompatibility issues)? Researchers will compare "recombinant humanized type III collagen plus progestin (experimental group)" to "high-dose progestin alone (control group)" to see if the combination therapy is more effective for fertility preservation. Participants will: 1. Take high-dose progestin (such as Medroxyprogesterone Acetate or Megestrol Acetate) orally every day. 2. If assigned to the experimental group, receive one intrauterine submucosal injection of collagen via hysteroscopy at months 0, 1, and 2, for a total of 3 injections. 3. Visit the clinic once every 3 months for treatment evaluation and follow-up, which includes hysteroscopic endometrial biopsy, imaging (such as transvaginal ultrasound), and safety tests for relevant biochemical indicators.
CONDITIONS
Official Title
Intrauterine Injection of Type III Collage in FST of EC/AEH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of endometrioid adenocarcinoma (G1 or G2) or atypical endometrial hyperplasia
- For endometrial cancer patients, MRI or ultrasound confirms lesion confined to endometrium or invades less than half of the myometrium (FIGO 2009 Stage IA)
- Age 45 years or younger
- Desire to preserve fertility and signed informed consent
- No serious medical comorbidities such as severe liver or renal dysfunction
- No contraindications to progestin therapy or pregnancy
- No evidence of distant metastasis on imaging
You will not qualify if you...
- Tumor invasion greater than half of the myometrium, or FIGO (2009) Stage IB and above
- Tumor differentiation grade 3 or non-endometrioid adenocarcinoma
- Presence of other malignant tumors
- Contraindications to conservative treatment or study drugs
- Known allergy to recombinant protein components
- Acute genital tract inflammation or untreated abnormal vaginal discharge within 2 weeks prior to enrollment
- Previous treatment with high-potency progestin for more than 1 month
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yiqin Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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