Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

Phase 2

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Etonogestrel

• Registration Number: NCT05791799
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-03-17
• Last Update Submitted: 2023-03-17
• Study First Posted: 2023-03-30
• Last Update Posted: 2023-03-30
• Study Start: 2023-04-01
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etonogestrel implants group	Etonogestrel	Women will be subjected to etonogestrel implant (68mg) insertion.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.