Reproductive Function in Women With Bipolar Disorder (NCT05307848) | Clinical Trial Compass
UnknownNot Applicable
Reproductive Function in Women With Bipolar Disorder
China200 participantsStarted 2021-03-01
Plain-language summary
Many studies have shown that patients with bipolar disorder are prone to reproductive dysfunction, including polycystic ovary syndrome, hyperprolactinemia, and amenorrhea. However, there is still considerable disagreement about the causes of reproductive dysfunction in patients with bipolar disorder. This study will evaluate the reproductive function of female patients with bipolar disorder without medication and those with bipolar disorder after stable medication, compared with the health control. The purpose of the study is to explore the influence, degree, and possible risk factors of bipolar disorder itself and drugs on the reproductive function of female patients.
Who can participate
Age range16 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. Subjects voluntarily participated in the trial and signed informed consent and were able to comply with planned visits, laboratory tests, and other study procedures；
✓. Meets the diagnostic criteria for bipolar disorder in the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) and has no coexisting psychiatric disorders；
✓. First diagnosis of bipolar disorder or stable medication for ≥6 months.
✓. Subjects voluntarily participated in the trial and signed informed consent and were able to comply with planned visits, laboratory tests, and other study procedures；
✓. No history of mental illness;
✓. No history of psychotropic medication.
Exclusion criteria
✕. Presence of any other medical disorder affecting reproductive endocrine function;
✕. Taking contraceptives, immunosuppressants, and other drugs that may affect reproductive function within six months;
What they're measuring
1
Changes in menstrual cycle at baseline and the sixth month
Timeframe: Baseline and the sixth month
2
Changes in reproductive hormone at baseline and the sixth month
Timeframe: Baseline and the sixth month
3
Changes in pelvic ultrasonography findings at baseline and the sixth month
. Currently pregnant, breastfeeding, or planning to become pregnant in perimenopause or postmenopause;
✕. Those with obvious suicidal tendencies;
✕. Serious neurological disease with a clear family history or underlying risk;
✕. Combining other severe acute or chronic diseases, mental diseases, or abnormal laboratory tests has clinical significance, and the subject is judged by the investigator to be unsuitable to participate in this study.