UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of ovarian preservation therapy in patients with systemic lupus erythematosus treated with cyclophosphamide pulse therapy - multi center observational study.
Title of the study (Brief title)	The efficacy of ovarian preservation therapy in patients with systemic lupus erythematosus treated with cyclophosphamide pulse therapy
Region	Japan

Condition
Condition	systemic lupus erythematosus
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of monthly GnRH against premenopausal ovarian impairment induced by intravenous cyclophosphamide therapy in patients with systemic lupus erythematosus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	The incidence of premenopausal ovarian insufficiency
Key secondary outcomes	parity pregnancy exacerbation of systemic lupus erythematosus

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients who had a diagnosis of SLE (fulfilled 4/11 American College of Rheumatology revised criteria) Patients who were eighteen years or older female. Patients who received more than 6 courses of IVCY Patients who provided a written informed concent.
Key exclusion criteria	Patients whom investigators judged inappropriate for this study.
Target sample size	100

Research contact person
Name of lead principal investigator	Atsushi Ihata
Organization	National Hospital Organization Yokohama Medical Center
Division name	Department of Rheumatology
Address	3-60-2, harajuku, Totsuka-ku, Yokohama city
TEL	045-851-2621
Email	ihata-atsushi@yokohamamc.jp

Public contact
Name of contact person	Atsushi Ihata
Organization	National Hospital Organization Yokohama Medical Center
Division name	Department of Rheumatology
Address	3-60-2, harajuku, Totsuka-ku, Yokohama city
TEL	045-851-2621
Homepage URL
Email	ihata-atsushi@yokohamamc.jp

Sponsor
Institute	National Hospital Organization Yokohama Medical Center, Department of Rheumatology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	横浜南共済病院（神奈川県）、横浜市立大学附属病院（神奈川県）、横浜市立大学附属市民医療センター（神奈川県）、国立病院機構横浜医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 07 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 03 Day
Anticipated trial start date	2016 Year 02 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Case control study. All patients with SLE who were treated with a monthly regimen of cyclophosphamide pulses for lupus nephritis at these institutes, between February 2016 and August 2016.

Management information
Registered date	2016 Year 02 Month 04 Day
Last modified on	2017 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024064