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

Anovulation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335879
• Other study ID #: GenSci 008 CT
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2015
• Last updated: January 9, 2015
• Start date: May 2008

Study information

• Verified date: January 2015
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 38 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anovulation

Intervention

Biological:
• Gonal-F

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Peking University First Hospital, Peking University People's Hospital, Qilu Hospital, Reproductive & Genetic Hospital of CITIC-Xiangya, Second Affiliated Hospital of Wenzhou Medical University, Second Hospital of Jilin University, Shengjing Hospital, The First Affiliated Hospital of Dalian Medical University, Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No