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 range
16 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. Presence of any other medical disorder affecting reproductive endocrine function;
. Taking contraceptives, immunosuppressants, and other drugs that may affect reproductive function within six months;
. 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.