Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter Prospective Randomized Controlled Clinical Study of Etonogestrel Implants to Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Etonogestrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemic lupus erythematosus was confirmed 18-37 years old Exclusion Criteria: History of sex chromosome abnormalities History of abnormal thyroid function History of abnormal adrenal function History of pituitary disease History of sexual hormone drug use in the past 3 months History of ovarian tumors or invasive ovarian operations Pregnancy Have a birth plan in the next 1 year Ovarian failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etonogestrel implants group<br>Women will be subjected to etonogestrel implant (68mg) insertion. | Drug: Etonogestrel<br>* Etongestrel implant will be implanted subcutaneously in the participant's non-dominant arm for one year<br>|
| No Intervention: control group<br>This group of women will not be intervened. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Mullerian hormone (AMH) serum level | The serum AMH levels of the two groups will be compared one year and three months after enrollment. | one year and three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of antral follicle | The number of antral follicles will be recorded by transvaginal ultrasound and compared one year and three months after enrollment. | one year and three months | 
| Follicle-stimulating hormone (FSH) serum level | The serum FSH levels of the two groups will be compared one year and three months after enrollment. | one year and three months | 
| luteinizing hormone (LH) serum level | The serum LH levels of the two groups will be compared one year and three months after enrollment. | one year and three months | 
| Estradiol (E2) serum level | The serum E2 levels of the two groups will be compared one year and three months after enrollment. | one year and three months |