Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05791799

Collaborator

(none)

180

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: Etonogestrel	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Etonogestrel implants group

Women will be subjected to etonogestrel implant (68mg) insertion.

Drug: Etonogestrel

Etongestrel implant will be implanted subcutaneously in the participant's non-dominant arm for one year

No Intervention: control group

This group of women will not be intervened.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 37 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sixth Affiliated Hospital, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT05791799

Other Study ID Numbers:

2022ZSLYEC-461

First Posted:

Mar 30, 2023

Last Update Posted:

Mar 30, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic

Etonogestrel

Study Results

No Results Posted as of Mar 30, 2023