Systemic Lupus Erythematosus
Conditions
Brief summary
This clinical trial aims to test in female patients with systemic lupus erythematosus (SLE). The main question it seeks to answer is whether etonogestrel implants can protect ovarian reserve function in patients with SLE. Participants will be randomly divided into a test group and a control group. The test group will be implanted subcutaneously with etongestrel for one year. Researchers won't intervene in the control group. After three months of drug-eluting, researchers will compare measures of ovarian reserve function in the test and control groups to see if etonogestrel implants can protect ovarian reserve function in patients with SLE.
Interventions
DRUGEtonogestrel
Etongestrel implant will be implanted subcutaneously in the participant's non-dominant arm for one year
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
1. Systemic lupus erythematosus was confirmed 2. 18-37 years old
Exclusion criteria
1. History of sex chromosome abnormalities 2. History of abnormal thyroid function 3. History of abnormal adrenal function 4. History of pituitary disease 5. History of sexual hormone drug use in the past 3 months 6. History of ovarian tumors or invasive ovarian operations 7. Pregnancy 8. Have a birth plan in the next 1 year 9. Ovarian failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Mullerian hormone (AMH) serum level | one year and three months | The serum AMH levels of the two groups will be compared one year and three months after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of antral follicle | one year and three months | The number of antral follicles will be recorded by transvaginal ultrasound and compared one year and three months after enrollment. |
| Follicle-stimulating hormone (FSH) serum level | one year and three months | The serum FSH levels of the two groups will be compared one year and three months after enrollment. |
| luteinizing hormone (LH) serum level | one year and three months | The serum LH levels of the two groups will be compared one year and three months after enrollment. |
| Estradiol (E2) serum level | one year and three months | The serum E2 levels of the two groups will be compared one year and three months after enrollment. |
Contacts
Primary ContactXiaoyan Liang
Outcome results
None listed