Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation
Primary Purpose
Anovulation
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gonal-F
Sponsored by
About this trial
This is an interventional treatment trial for Anovulation
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Recombinant Human Follitropin
Arm Description
Outcomes
Primary Outcome Measures
The efficiency reached mature follicle (the diameter of follicular ≥18mm by type-B ultrasonic) within the start period on the day of HCG day.
Secondary Outcome Measures
Full Information
NCT ID
NCT02335879
First Posted
January 5, 2015
Last Updated
January 9, 2015
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Peking University People's Hospital, Peking University First Hospital, Reproductive & Genetic Hospital of CITIC-Xiangya, Qilu Hospital of Shandong University, Wuhan Union Hospital, China, Second Hospital of Jilin University, Shengjing Hospital, The First Affiliated Hospital of Dalian Medical University, Second Affiliated Hospital of Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02335879
Brief Title
Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Peking University People's Hospital, Peking University First Hospital, Reproductive & Genetic Hospital of CITIC-Xiangya, Qilu Hospital of Shandong University, Wuhan Union Hospital, China, Second Hospital of Jilin University, Shengjing Hospital, The First Affiliated Hospital of Dalian Medical University, Second Affiliated Hospital of Wenzhou Medical University
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anovulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
534 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recombinant Human Follitropin
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Gonal-F
Primary Outcome Measure Information:
Title
The efficiency reached mature follicle (the diameter of follicular ≥18mm by type-B ultrasonic) within the start period on the day of HCG day.
Time Frame
participants will be followed within the HCG day, an expected average of 14±2 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation
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