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Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires

Efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: This study will do 2 things: It will conduct patient surveys."
  • "Participants will complete a one-time survey."
  • "Participants can take the survey in 4 ways: On paper, sent through the mail."
  • "The survey will take about 30 minutes."
  • "This may include their symptoms and the results of their blood tests."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether a drug called GnRHa helps protect the ovaries during cyclophosphamide (CYC) treatment for lupus (SLE). It compares women treated with CYC, with or without GnRHa, and women with lupus who have not received CYC. Researchers use a one-time, 30-minute survey and medical records.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women with lupus (SLE).
  • For the CYC groups: younger than 40 when CYC treatment began.
  • One CYC group received CYC without GnRHa.
  • The other CYC group received CYC with leuprolide acetate, a GnRHa drug, at 3.75 mg each month or 11.25 mg every 3 months.
  • For the comparison group: women of similar ages who have never received CYC.

Who can't join

  • For the CYC groups: older than 40 when CYC treatment began.
  • Any past problems with the reproductive organs, such as the ovaries or womb.
  • A history of infertility, meaning trouble getting pregnant.
  • Untreated sexually transmitted infections (STIs), which are infections passed through sexual contact.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* ELIGIBILITY CRITERIA: * INCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone SLE females \<40 years at the beginning of CYC treatment without GnRH-a cotreatment. -EXCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone Females \>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated sexually transmitted infections (STIs). -INCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg/month or 11.25mg/every 3 months. SLE females \<40 years at the beginning of CYC treatment with GnRH-a cotreatment. -EXCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg/month or 11.25mg/every 3 months. Females \>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated STIs. -Group: Control subjects. Age-matched female SLE patients without a history of reproductive disorders, infertility, or untreated STIs, who have not received CYC either with or without GnRH-a.

Study sites (1)

MD