Primary ovarian failure
Conditions
Interventions
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
30 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Duration of amenorrhea>=4 months with more than 4 weeks between periods; FSH>40 U/L and desire for pharmacological treatment; 2. Good overall health status as indicated by medical history, physical examination, gynecological examination, and laboratory findings (except for POF-related symptoms); 3. Cervical smear results are normal or not clinically significant within the past 6 months. Human papillomavirus (HPV) testing may be used as an adjunct test for patients presenting with atypical squamous cells of undetermined significance (ASCUS). If high-risk HPV testing shows negative, the patients of ASCUS can be enrolled in the study; 4. Patients without endometrial lesions. Endometrial biopsy can be performed if necessary; 5. Patients have not received hormone supplementation within the past 3 months; 6. Adult women aged 30 to 40 years) who experienced menstrual periods, better with previous childbirth (not mandatory), non-pregnant and non-lactating; 7. Organ function is good, biochemical examination meets the following conditions: AST <= 2.5 x upper limit of normal value (ULN), ALT <= 2.5 x upper limit of normal value (ULN), serum total bilirubin <= 1.5 x upper limit of normal value (ULN), creatinine <= 1.5 x upper limit of normal (ULN); 8. Informed consent has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation (delivery, miscarriage or breastfeeding less than 3 months after the start of treatment); 2. Allergic to any component of the study drug; 3. Any disease that requires immediate blood transfusion; 4. Any disease or condition that may affect the conduct of the study or the interpretation of the results, including: (1) Known severe coagulation disorders (known pulmonary embolism, deep vein thrombosis, DIC, thrombocytopenia, etc.); (2) Known severe anemia (Hgb30 mm; (6) Unexplained ovarian tumors or pelvic masses require further diagnosis; (7) Known or suspected endometrial polyps >15 mm; (8) Known uterine fibroids larger than 4 cm with surgical indications. 5. Abuse of alcohol, drugs or drugs (eg, laxatives); 6. Undiagnosed abnormal bleeding in the reproductive system; 7. Participate in another drug clinical study at the same time; 8. Participation in another clinical trial that may have an impact on the purpose of this study prior to study inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anti-mullerian hormone ;Sex hormones (6 items); | — |
Secondary
| Measure | Time frame |
|---|---|
| Follicle count;Menstrual status;Symptoms of low estrogens on daily life;Size of follicle-like structures containing follicles and functional ovarian cysts; | — |
Countries
China
Contacts
Public ContactDeng Shan
Peking Union Medical College Hospital
Outcome results
None listed