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

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).

Study Overview

• Status: Completed
• Conditions: Anovulation
• Intervention / Treatment: Biological: Gonal-F

• Study Type: Interventional
• Enrollment (Actual): 534
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recombinant Human Follitropin	Biological: Gonal-F

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: January 5, 2015
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 12, 2015

Study Record Updates

• Last Update Posted (Estimate): January 12, 2015
• Last Update Submitted That Met QC Criteria: January 9, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Anovulation
• Other Study ID Numbers: GenSci 008 CT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No