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NCT Number: NCT05567198

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Adnexal Diseases Autoimmune Diseases Connective Tissue Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Ovarian Diseases Primary Ovarian Insufficiency Primary Ovarian Insufficiency (Poi) Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–120 year

Sex eligibility

Female

Study type

Observational

Primary location

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Bethesda, Maryland, 20892, United States

Location status: Recruiting

Location contact

Sarfaraz Hasni, M.D.

CONTACT

[email protected]

301-451-1599

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. POI

    Time frame: End of study

    The primary outcome variable is POI, and we want to determine whether GnRH-a coadministration with CYC protects against POI incidence in pre-menopausal SLE females. The age of menopause onset will be collected from previous medical records or survey responses and compared across all three groups. Onset of menopause prior to the age of 40 will be considered POI, whereas menopause onset beyond the age of 40 will be considered natural menopause.

Secondary outcomes

  1. Record Effects of CYC administration with GnRH-a on menstrual cycle

    Time frame: End of study

    • Menses cycles will be classified as either regular (consistently having a period of normal duration each month) or irregular (frequent, infrequent, or absent periods). Classifications of irregular cycle subcategories will be provided, which include polymenorrhea (frequent periods with a cycle length <21 days), oligomenorrhea (infrequent menses with cycle length between 37 to 90 days), or amenorrhea (absence of a period for >90 days). - Menopausal signs and symptoms will include vaginal dryness, hot flashes, chills, sleeping disturbances, night sweats, mood changes, weight gain, loss of breast fullness, thinning hair, or dry skin. - Inability to conceive will be defined as 12 months of trying to conceive without success.

  2. SLE disease activity as measured by SELENA-SLEDAI score at the start of CYC treatment

    Time frame: End of study

    These include SLE disease activity as measured by SELENA-SLEDAI score at the start of CYC treatment, damage index score as measured by SLICC/ACR DI, cumulative CYC dose, and age at the time of beginning CYC.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarfaraz A Hasni, M.D.

CONTACT

[email protected]

(301) 451-1599

Sponsors and collaborators

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Nih

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 5, 2022
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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