Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
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| ClinicalTrials.gov Identifier: NCT05567198 |
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Recruitment Status :
Recruiting
First Posted : October 5, 2022
Last Update Posted : October 25, 2023
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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.
| Condition or disease |
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| Systemic Lupus Erythematosus (Sle) Primary Ovarian Insufficiency (Poi) |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires |
| Actual Study Start Date : | March 3, 2023 |
| Estimated Primary Completion Date : | May 31, 2024 |
| Estimated Study Completion Date : | May 31, 2024 |
| Group/Cohort |
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Group 1
SLE patients receiving CYC alone
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Group 2
SLE patients receiving both CYC and leuprolide acetate (GnRH-a)
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Group 3
Control subjects, Age-matched female SLE patients without a history of reproductive disorders
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- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05567198
| Contact: Sarfaraz A Hasni, M.D. | (301) 451-1599 | hasnisa@mail.nih.gov |
| United States, Maryland | |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Sarfaraz Hasni, M.D. 301-451-1599 hasnisa@mail.nih.gov | |
| Principal Investigator: | Sarfaraz A Hasni, M.D. | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| Responsible Party: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT05567198 |
| Other Study ID Numbers: |
10001011 001011-AR |
| First Posted: | October 5, 2022 Key Record Dates |
| Last Update Posted: | October 25, 2023 |
| Last Verified: | October 23, 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Primary Ovarian Insufficiency (Poi) Nephritis Neuro-Psychiatric Lupus Anti-Mullerian Hormone (Amh) Natural History |
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Primary Ovarian Insufficiency Menopause, Premature Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Gonadal Disorders Endocrine System Diseases |