Anovulation
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Domestic Recombinant Human Follitropin (Gonal-F) for Injection for treatment of WHO Ⅱ anovulation (including polycystic ovarian syndrome \[PCOS\] subjects).
Interventions
BIOLOGICALGonal-F
Sponsors
Peking University People's Hospital
Peking University First Hospital
Reproductive & Genetic Hospital of CITIC-Xiangya
Qilu Hospital of Shandong University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Second Hospital of Jilin University
Shengjing Hospital
The First Affiliated Hospital of Dalian Medical University
Second Affiliated Hospital of Wenzhou Medical University
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* Married infertile women at the age of 21-38. * BMI\<28kg/m2. * According to the detection level of serum estradiol (E2), prolactin (PRL), progesterone (P), testosterone (T), luteinizing hormone (LH), follicle stimulating hormone (FSH), subjects were diagnosed of WHO class II anovulation or oligo-ovulation, and the above hormone level of the subject is normal or normal after treatment at the beginning of study, and FSH\<10IU/L. * Bilateral fallopian tubes are unobstructed proved by hysterosalpingograph or laparoscopic examination within one year, no history of abortion or pelvic infection after the examination, the researcher decide whether the above examination need to repeat. If the subject had salpingoplasty under laparoscope, and the bilateral fallopian tubes are unobstructed after the surgery, there is no need to have the hysterosalpingograph. If it can not be confirmed, it must be done again to prove that the bilateral fallopian tubes are unobstructed. * Vaginal B-ultrasound examination shows that there is no ovarian pathological tumor, no hysteromyoma or hysteromyoma\<4cm, and does not affect the endometrial function. * Two examinations of spouse semen are normal within six months, or comply with the IUI standard. * No history of drug abuse. * Voluntarily sign the informed consent form and agree with medication and accepting evaluation according to the requirements of the research protocol.
Exclusion criteria
* The subject use gonadotropin therapy within the past three months (regardless the result of treatment). * The uterine factors affect pregnancy and other tumors. * Pregnancy contraindication, such as genetic diseases, mental diseases, drug abuse, sexually transmitted diseases, severe heart disease and hepatic and kidney function insufficiency. * Obscure vaginal bleeding. * Subjects are allergic to the application of FSH/HMG and HCG in the past. * Other conditions that the researchers think they are not suitable for the clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficiency reached mature follicle (the diameter of follicular ≥18mm by type-B ultrasonic) within the start period on the day of HCG day. | participants will be followed within the HCG day, an expected average of 14±2 days |
Outcome results
None listed