Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05567198
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2022-10-04
Brief Title:
Gonadotropin-releasing Hormone Agonist GnRHa in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Efficacy of Gonadotropin-releasing Hormone Agonist GnRHa in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Status:
RECRUITING
Status Verified Date:
2024-05-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Systemic lupus erythematosus SLE is a disease that affects females nine times more often than males People with SLE are often treated with cyclophosphamide CYC But CYC can damage a woman s ovaries it may cause infertility A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy But no one really knows how effective GnRHa treatment is This natural history survey will compare women who received GnRHa during CYC therapy with those who did not
Objective
To find out whether GnRHa can help protect women s ovaries during CYC
Eligibility
Women under age 40 years starting CYC treatment with or without GnRHa
Design
This study will do 2 things It will conduct patient surveys It will collect data from medical records
Participants will complete a one-time survey They will answer questions about their menstrual cycle They will be asked about their history of pregnancy or infertility
Participants can take the survey in 4 ways
On paper sent through the mail
Online in a secure web page managed by the NIH
By phone
In person during a routine visit to the NIH clinic
The survey will take about 30 minutes
Participants medical records will be reviewed Researchers will look for data about the participants SLE disease This may include their symptoms and the results of their blood tests It may also include the details of prior treatments
Researchers will also collect data about participants reproductive history This may include their personal or family history of infertility It may include any fertility treatments and any sexually transmitted infections
Systemic lupus erythematosus SLE is a disease that affects females nine times more often than males People with SLE are often treated with cyclophosphamide CYC But CYC can damage a woman s ovaries it may cause infertility A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy But no one really knows how effective GnRHa treatment is This natural history survey will compare women who received GnRHa during CYC therapy with those who did not
Objective
To find out whether GnRHa can help protect women s ovaries during CYC
Eligibility
Women under age 40 years starting CYC treatment with or without GnRHa
Design
This study will do 2 things It will conduct patient surveys It will collect data from medical records
Participants will complete a one-time survey They will answer questions about their menstrual cycle They will be asked about their history of pregnancy or infertility
Participants can take the survey in 4 ways
On paper sent through the mail
Online in a secure web page managed by the NIH
By phone
In person during a routine visit to the NIH clinic
The survey will take about 30 minutes
Participants medical records will be reviewed Researchers will look for data about the participants SLE disease This may include their symptoms and the results of their blood tests It may also include the details of prior treatments
Researchers will also collect data about participants reproductive history This may include their personal or family history of infertility It may include any fertility treatments and any sexually transmitted infections
Detailed Description:
Study Description SLE patients with life-threatening lupus manifestations are often treated with cyclophosphamide CYC which has known cytotoxic effects on ovarian reserve Co-administration of Gonadotropinreleasing hormone agonist GnRHa is suggested to protect ovaries from the cytotoxic effects of CYC but there is lack of data to support this We hypothesize that the co-administration of a GnRH agonist for the duration of CYC therapy will exert protective effects on ovarian reserve and function in SLE females We plan to do a patient survey and a retrospective data collection to compare ovarian function in subjects who received CYC with GnRHa to those who received CYC without GnRHa
Objectives
Primary Objective Determine the effectiveness of GnRH-a in preventing primary ovarian insufficiency POI in female SLE patients getting cyclophosphamide treatment
Secondary Objectives Determine the effects of SLE disease activity damage accrual cumulative dose of cyclophosphamide and other demographic and clinical variables in preventing primary ovarian insufficiency
Objectives
Primary Objective Determine the effectiveness of GnRH-a in preventing primary ovarian insufficiency POI in female SLE patients getting cyclophosphamide treatment
Secondary Objectives Determine the effects of SLE disease activity damage accrual cumulative dose of cyclophosphamide and other demographic and clinical variables in preventing primary ovarian insufficiency
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001011-AR | None | None | None |