Fertility Sparing
Conditions
Brief summary
In modern society, endometrial cancer (EC) and atypical hyperplasia is the most frequent desease which can affect the fertility of young patients. For young patients, there is a growing need to treat tumors and fertility sparing. Advaced studies have confirmed thatfertility preservation therapy has better tumor and pregnancy outcomes in specific patients with early gynecological tumors. Clinically, evidence-based guidelines are urgently needed to guide the screening and treatment of women who are suitable for fertility preservation. Fertility-sparing treatment predominantly involves the use of oral progestins and levonorgestrel-releasing intrauterine devices, which have been shown to be feasible and safe in women with early stage EC and minimal or no myometrial invasion. However, data on the efficacy and safety of conservative management strategies are primarily based on retrospective studies.The present study aims to compared the therapeutic effect of Medroxyprogesterone acetate (MPA) and Levonorgestrel-releasing intrauterine system (LNG-IUS) in early-stage endometrioid carcinoma and atypical hyperplasia patients
Interventions
DRUGMedroxyprogesterone Acetate 500 MG Oral Tablet
500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate At a dosage of 500 mg/day
Uterine cavity insertion
Sponsors
Hua Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | 24-week | The 24-week CR rate will be calculated in two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve complete response | From date of randomization until the date of CR, assessed up to 24 weeks | The median CR time will be calculated in two groups |
| The pregnancy rate | Up to 2 years after the treatment | Rate of fertility outcomes |
| The live-birth rate | Up to 2 years after the treatment | Rate of fertility outcomes |
Countries
China
Contacts
Primary ContactHengzi Sun, Ph.D
Outcome results
None listed