Primary Ovarian Insufficiency
Conditions
Brief summary
To evaluate the efficacy and safety of Kuntai capsule alone or combined with hormone therapy in improving ovarian function in POI patients (including subclinical stage).
Detailed description
The study is expected to be conducted between 2021.08 and 2023.12.120 subjects with early-onset ovarian insufficiency will be randomly assigned to trial, control, or combination groups using a computer-generated randomization table.By comparing the data of primary efficacy indexes, secondary efficacy indexes and safety indexes before and after medication, The principal investigator will write and publish the paper.
Interventions
DRUGKuntai Capsule
The instructions is pointed that each Kuntai capsule is 0.5g and the usage of Kuntai capsule is oral taking 4 capsules each time, 3 times a day, and 4 weeks is a course of treatment. The patients will taking 3 courses of treatment in this study.
DRUGFemoston
The estrogen and progesterone sequential regimen was adopted. The Femoston was contain estradiol tablets and estradiol didroxyprogesterone tablets. Red tablets (estradiol, 2 mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2 mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and three courses of treatment were taken. The patients will taking 3 courses of treatment in this study.
Sponsors
Affiliated Hospital of Nantong University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
blind experiment
Intervention model description
Subclinical POI and POI patients
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
1. The women aged \<40 years old. 2. Serum basal follicle stimulating hormone (FSH) level ≥15 IU/L at least twice inspection (two occasions \>4 weeks apart). Rare menstruation or menopause for at least 4 months. 3. Individuals meeting the above criteria who voluntarily consented to study participation.
Exclusion criteria
1. Pregnant and lactating patients; 2. Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma \> 4cm or hysterectomy; 3. Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor; 4. Patients with personal history of venous thromboembolism (VTE) or high risk of VTE (including body mass index \> 30 kg/m2, smoking and family history of thrombosis); 5. Patients with porphyria; 6. Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system; 7. Patients who are participating in other clinical trials or have participated in other clinical trials in the past three months; 8. Patients who suspect or have a history of alcohol and drug abuse; 9. Patients who are known to be allergic to the test drugs or their components; 10. The researchers determined that patients are not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Follicle-stimulating hormone (FSH) | Baseline, 3 months, 6 months | Changes of the level of FSH before and after treatment |
| Kupperman Score | Baseline, 3 months, 6 months | Changes of the Kupperman score before and after treatment，Kupperman Score ranges from 0 to 69, with the smaller the score, the better off the subject |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antral follicle count (AFC) | Baseline, 3 months, | Changes of the AFC before and after treatment |
| anti-Müllerian hormone (AMH) | Baseline, 3 months, | Changes of the level of AMH before and after treatment |
| The peak systolic blood flow velocity （PSV） | Baseline, 3 months, | The peak systolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound |
| Luteinizing hormone (LH) | Baseline, 3 months, 6 months | Changes of the level of LH before and after treatment |
| Uterine artery resistance index（RI） | Baseline, 3 months, | The uterine artery resistance index before and after treatment was assessed by vaginal B ultrasound |
| Proportion of patients with normal menstruation | Baseline，3 months, 6 months, 9 months | To measure the ratio of patients have normal menstruation after treatment |
| Pregnancy situation | 6 months | To ask the patient if there is pregnancy (for patient who has pregnancy need) |
| The end-diastolic blood flow velocity（EDV） | Baseline, 3 months, | The uterine artery end-diastolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound |
| Estradiol hormone (E2) | Baseline, 3 months, 6 months | Changes of the level of Estradiol hormone before and after treatment |
Countries
China
Contacts
Primary ContactYuquan Zhang, Professor
Backup ContactWeina Wang, Postgraduate
Outcome results
None listed