Clinical trial NCT02335879: Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anovulation
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University People's Hospital
name: Peking University First Hospital
name: Reproductive & Genetic Hospital of CITIC-Xiangya
name: Qilu Hospital of Shandong University
name: Wuhan Union Hospital, China
name: Second Hospital of Jilin University
name: Shengjing Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: Second Affiliated Hospital of Wenzhou Medical University
First posted: 2015-01-12
Enrollment: 534
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: The efficiency reached mature follicle (the diameter of follicular ≥18mm by type-B ultrasonic) within the start period on the day of HCG day.
timeFrame: participants will be followed within the HCG day, an expected average of 14±2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: