PCOS
Conditions
Interventions
experimental group:Hydroxychloroquine
control group:Placebo
Sponsors
International Peace Maternal and Child Health Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be included in the study: 1. Chinese women aged 20-38 years. 2. According to the Rotterdam PCOS diagnostic criteria, 2 of the following 3 items are met: (1) rare ovulation or no ovulation. (2) Clinical manifestations of hyperandrogenism or high androgen (such as hairy, hemorrhoids, etc.). (3) Ultrasound examination occurred in the menstrual cycle or after 3 to 5 days of hemorrhage after progesterone withdrawal, showing that both ovaries have >= 12 small follicles with a diameter of 2 to 9 mm, ie ovarian polycystic changes, and/or ovaries The volume is increased (>10 mL per side, ovarian volume = 0.15 x long cm x width cm x thickness cm). 3. No contraception for more than 1 year of pregnancy; no previous treatment for pregnancy. 4. Fully explain the nature of the study and obtain informed consent from the subject before performing any procedures specified in the study protocol. If the subject is incapable of expressing an opinion, written informed consent may be signed by the subject's legal representative.
Exclusion criteria
Exclusion criteria: Any of the following criteria should be excluded from the study: 1. Other diseases of the endocrine system: hypertension, metabolic syndrome, etc. 2. Have done unilateral oophorectomy; 3. There are chromosomal abnormalities in both sides of the wife, and PGT is required; 4. Other causes of hyperandrogenism, such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, androgen secreting tumor, 21-hydroxylase deficiency atypical adrenal hyperplasia, exogenous androgen Application, etc. 5. Infertility with combined immune factors; 6. Uterine abnormalities such as uterine malformation (single-horned uterus, mediastinal uterus, double uterus, double-horned uterus), uterine adenomyosis, submucosal fibroids or intrauterine adhesions; 7. History of recurrent abortion (including biochemical pregnancy), which is a history of abortion 3 or more; 8. Contraindications for the treatment or application of hydroxychloroquine: liver disease or abnormal liver function (unused serum enzyme index); renal disease or renal dysfunction; severe anemia; history of deep vein thrombosis, history of pulmonary embolism, History of cerebrovascular accidents; diagnosis of a clear heart disease; history of cervical cancer, endometrial cancer or breast cancer; vaginal bleeding of unknown origin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical pregnancy outcome;Spontaneous abortion rate;Ongoing pregnancy rate; | — |
Countries
China
Contacts
Public ContactLin Xianhua
International Peace Maternal and Child Health Hospital
Outcome results
None listed