Collagen injections into the uterus alongside hormone treatment for early endometrial cancer
Tests collagen injected into the uterus plus progestin in women wanting to keep fertility.
Plain-language title generated from the registry record
Registry title: Intrauterine Injection of Type III Collage in FST of EC/AEH
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 45 with early endometrial cancer or atypical endometrial hyperplasia who want to keep their fertility and have not yet had strong progestin treatment.
- Age
- 18 to 45 years
- Sex
- Women only
- Disease stage
- Endometrioid adenocarcinoma grade G1 or G2, or atypical endometrial hyperplasia. For cancer, the lesion must stay in the endometrium or reach less than 1/2 of the myometrium (FIGO 2009 Stage IA), with no distant spread on imaging.
- Earlier treatment
- Cannot have had high-potency progestin for more than 1 month before.
Main reasons for not taking part
- Tumor grows deeper than 1/2 of the myometrium, or FIGO (2009) Stage IB or higher
- Tumor grade G3 or not endometrioid adenocarcinoma
- Another cancer at the same time
- Known allergy to recombinant protein components
- Acute genital tract inflammation or untreated abnormal vaginal discharge within 2 weeks before enrollment
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT07377734, who can take part
Where in China
- Peking University People's HospitalBeijing, ChinaContact: Yiqin WangTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Wang Jianliu
- Trial code
- NCT07377734
- Record updated
- 30 March 2026
- Original description
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:Read full original descriptionShow less
A Multicenter, Randomized, Open-Label, Controlled Clinical Trial of Intrauterine Injection of Recombinant Humanized Type III Collage in the Fertility-Sparing Treatment of Endometrial Cancer or Atypical Hyperplasia
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.
Inclusion: Pathological diagnosis of endometrioid adenocarcinoma (G1 or G2) or atypical endometrial hyperplasia; For patients with endometrial cancer, magnetic resonance imaging (MRI) or ultrasound must confirm that the lesion is confined to the endometrium or invades less than 1/2 of the myometrium (i.e., FIGO 2009 Stage IA); Age ≤ 45 years; Desire to preserve fertility and signed informed consent; No serious medical comorbidities (e.g., severe liver or renal dysfunction); No contraindications to progestin therapy or pregnancy; No evidence of distant metastasis on imaging.
Exclusion: Contraindications to conservative treatment or use of the study drugs; 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; Coexistence of other malignant tumors; Known allergy to recombinant protein components; Tumor invasion > 1/2 of the myometrium, or FIGO (2009) Stage IB and above; Tumor differentiation grade G3 or non-endometrioid adenocarcinoma.