Actively Recruiting
Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC
Led by West China Second University Hospital · Updated on 2021-09-13
224
Participants Needed
1
Research Sites
665 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary end points: This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome. Second end points: To analyze the appearances of side-effects.
CONDITIONS
Official Title
Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or younger
- Strong desire to preserve fertility
- Histological diagnosis of well-differentiated (grade 1) endometrioid adenocarcinoma with positive progesterone receptors or atypical endometrial hyperplasia confirmed by designated gynecological pathologists
- Disease limited to the endometrium (stage 1A) on MRI (for endometrial cancer patients)
- Normal serum CA125/199 levels (with laparoscopic exploration if necessary to rule out ovarian tumor or metastasis)
- Volunteered to participate, signed informed consent, and agreed to clinical follow-up
You will not qualify if you...
- Allergies or contraindications to study drugs or device (except thromboembolic disease, liver dysfunction, hypertension, and diabetes)
- Diagnosis of Lynch syndrome (endometrial cancer patients only)
- Contraindications for pregnancy
- Serious underlying diseases, other malignancies, acute liver or kidney disease, acute or subacute genital tract infections
- Congenital or acquired uterine abnormalities preventing intrauterine device placement
- Refusal to participate in clinical follow-up or to sign informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Second University Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
Z
ZHENG Ying, Professor
CONTACT
C
CHEN Si Jing, postgraduate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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