Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation

GeneScience Pharmaceuticals (GenSci)

Status and phase

Completed

Phase 3

Conditions

Anovulation

Treatments

Biological: Gonal-F

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02335879

GenSci 008 CT

Details and patient eligibility

About

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).

Enrollment

534 patients

Sex

Female

Ages

21 to 38 years old

Volunteers

No Healthy Volunteers

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.