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Minor10 versionsRe-verified since Mar 31, 2026, no change to tracked fieldsv130-v139
NotablePrimary and study completion dates: May 31, 2026 to May 31, 2027v129
NotablePrimary completion date: May 31, 2025 to May 31, 2026v128
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MinorStudy completion date: May 31, 2025 to May 31, 2026v127
MinorRe-verified, no change to tracked fieldsv126
NotablePrimary and study completion dates: May 31, 2024 to May 31, 2025v125
Minor3 versionsRe-verified since Oct 24, 2023, no change to tracked fieldsv122-v124
NotablePrimary and study completion dates: May 31, 2023 to May 31, 2024v121
MinorStart date changed from estimate of Apr 6, 2023 to Mar 3, 2023v120
MinorRe-verified, no change to tracked fieldsv119
MinorStart date: Apr 4, 2023 to Apr 6, 2023v118
MinorStart date: Apr 3, 2023 to Apr 4, 2023v117
MinorStart date: Mar 31, 2023 to Apr 3, 2023v116
MinorStart date: Mar 30, 2023 to Mar 31, 2023v115
MinorStart date: Mar 28, 2023 to Mar 30, 2023v114
MinorStart date: Mar 27, 2023 to Mar 28, 2023v113
MinorStart date: Mar 24, 2023 to Mar 27, 2023v112
MinorStart date: Mar 22, 2023 to Mar 24, 2023v111
MinorStart date: Mar 21, 2023 to Mar 22, 2023v110
MinorStart date: Mar 20, 2023 to Mar 21, 2023v109
MinorStart date: Mar 19, 2023 to Mar 20, 2023v108
MinorStart date: Mar 16, 2023 to Mar 19, 2023v107
MinorStart date: Mar 15, 2023 to Mar 16, 2023v106
MinorStart date: Mar 14, 2023 to Mar 15, 2023v105
MinorStart date: Mar 13, 2023 to Mar 14, 2023v104
MinorStart date: Mar 12, 2023 to Mar 13, 2023v103
MinorStart date: Mar 9, 2023 to Mar 12, 2023v102
MinorStart date: Mar 8, 2023 to Mar 9, 2023v101
MinorStart date: Mar 7, 2023 to Mar 8, 2023v100
MinorStart date: Mar 6, 2023 to Mar 7, 2023v99
MinorStart date: Mar 5, 2023 to Mar 6, 2023v98
MinorStart date: Mar 2, 2023 to Mar 5, 2023v97
MinorStart date: Feb 28, 2023 to Mar 2, 2023v96
MinorStart date: Feb 24, 2023 to Feb 28, 2023v95
MinorStart date: Feb 23, 2023 to Feb 24, 2023v94
MinorStart date: Feb 22, 2023 to Feb 23, 2023v93
MinorStart date: Feb 21, 2023 to Feb 22, 2023v92
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.