NCT05307848

Reproductive Function in Women With Bipolar Disorder

Reproductive Function in Women With Bipolar Disorder: a Prospective Observational Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Central South University · Academic / Other
• Sex: Female
• Age: 16 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will comprise 60 female patients with bipolar disorder without medication, 60 female patients with bipolar disorder after stable prescription for ≥6 months, and 60 age and BMI-matched healthy controls. All of whom gave informed consent. All participants will be assessed and clinically examined at baseline, and all patients are encouraged to follow up in the sixth month. Baseline assessments will include demographics, menstrual records, comprehensive medical history, anthropometric measurements (weight and height), physical examination, pelvic ultrasound, and laboratory work (e.g., reproductive hormones). The follow-up of patients will include menstrual records, pelvic ultrasound, and reproductive hormones. Clinical symptoms will be assessed by Hamilton Depression Scale, Hamilton Anxiety Scale, and Young Mania Rating Scale at baseline and week 24. The cognitive function will be assessed at baseline and the sixth month with the Reusable Assessment of Neuropsychological Status Battery (RBANS) and the Stroop Color-Word Test. The primary outcomes will be menstruation, reproductive hormone levels, and pelvic ultrasound. Secondary outcomes will include overall psychiatric symptomatology, quality of life, cognitive function, and other biological data.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2022-04-01
• Last updated: 2022-04-01

Locations

1 site across 1 country: China